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Conference report

Opening Evening in the European Parliament

The meeting started with a well-attended evening event AESGP also had the honour of the presence of Commis-
in the European Parliament hosted by Adina-Ioana sioner Vytenis Andriukaitis who, in his speech, shared
Vlean, Chair of the Committee on the Environment, his thoughts on the role of self-care in managing the
Public Health and Food Safety (European Parliament), increasing pressure on health systems. A greater focus
who cordially welcomed participants and underlined the on prevention and prophylaxis in addition to early di-
importance of the self-care industry for offering product agnostics and treatment are essential stressed Mr An-
choices and for providing the necessary information. driukaitis, self-care and empowerment can make pa-
tients more autonomous and by extension less depend-
ent on our health systems.

At the AESGP event in the European Parliament on 10 October 2017 (from left to right): Hubertus Cranz (AESGP Director General),
Adina-Ioana Vlean (European Parliament), Vytenis Andriukaitis (European Commission), Renate Sommer (European Parliament),
and Dirk Ossenberg-Engels (AESGP Vice-President, Bayer Consumer Care)

Two projects relating to self-care have been funded by sistance (AMR), one of the major priorities for the Com-
the European Commission: PiSCE, a project of self-care mission which adopted the EU One Health Action Plan
systems in the EU, and PRO STEP, which promotes self- against AMR. He outlined that in July the Commission
care in chronic diseases. The PiSCE project developed published guidelines on the prudent use of antimicrobi-
guidelines and communication tools on how to pro- als in human medicine, which stress the importance of
mote self-care for chronic diseases. This can contribute avoiding treatment when there is only evidence of a
to improved patient centred care. The Commissioner viral infection such as the flu or of an infection after rel-
furthermore stated : The project also provides recom- evant clinical examination. Non-prescription medicines
mendations for the implementation of non-prescription can play an important role in alleviating the symptoms
drugs and stresses the importance of early involvement of patients who do not require antibiotics to treat minor
of stakeholders, training of health professionals and ailments and disorders.
improving the knowledge and skills of citizens and pa-
tients. He underlined the investment in self-care as an At the end of his speech, he stressed the collective re-
integral part of health literacy in education system. sponsibility in the development of healthy societies and
sustainable health systems, encouraged an open and
The Commissioner explained the patients need for insightful debate including all stakeholders and wished
tools to strengthen their knowledge and better monitor the participants a fruitful conference.
their condition. This includes a wide range of medical
devices and mHealth tools, some of them used in a self- AESGP Director General, Hubertus Cranz, thanked both
care context, whose safety and effectiveness will be Mrs Vlean and Commissioner Andriukaitis for their im-
ensured by the two new Regulations. portant statements and underlined the commitment of
the European self-care industry to address healthcare
Mr Andriukaitis also focused on anti-microbial re- challenges such as antimicrobial resistance.

Food Products and Health

Session 1
Which Direction to Go?

The Health Claims Regulation - A Mistake The EU and its institutions did therefore not want to
from the Very Beginning? prevent such innovation, although the Commission did
attempt to regulate the use of food supplements and
medical components in foodstuffs. She remarked that
Dr Renate Sommer introduced the session with an an-
from her perspective the scientific evaluation with re-
ecdote about how difficult it was for her daughter to
gard to the amounts of vitamins and minerals that may
find regular milk in the United States. Almost all types
be added to foodstuffs in the EU was quite successful.
of milk were labelled as fortified or lactose free. She is
She believes that Regulation (EC) No 1925/2006 on the
glad that we do not yet live in such conditions because
addition of vitamins and minerals and of certain other
EU requirements for making such claims are very high.
substances to foods ensures that food supplements are
However, she remarked that the US legal setting might
added in a manner that ensures a positive effect on
be preferable for some manufacturers. The market for
health while preventing an oversupply of certain sub-
foodstuffs is saturated and it makes sense to add to
stances. However, regarding advertising of these inno-
food to make it functional to place new products on the
vative foods, she believes the EU has failed.
market. She pointed to the success of functional foods
and the willingness of consumers to pay a higher price
Large parts of the Nutrition and Health Claims regula-
for them in the supermarket. She noted that lots of pro-
tion, Regulation (EC) No 1924/2006, that was intended
ducers of functional foods and food supplements are
to regulate advertising claims, are not in force yet. The
Small and Medium-sized Enterprises (SMEs), who con-
evaluation of the vast majority of claims submitted for
stitute the draft force of economic growth in the EU.
approval took years and 80% of evaluated claims were

Conference report

denied. She added that this was also a heavy burden for tions in the Parliament show that MEPs are sceptical
EFSA. That was when the EU postponed the evaluation towards new claims, and rejected several claims such as
of botanicals claims. Up until now, there has been no the effect of caffeine or carbohydrates. Mrs Sommer
new progress on 1600 claims on botanicals leading to concluded that from her perspective ideally all health
market distortion and legal uncertainty for all stake- claims should be banned.
holders. Manufacturers whose claims have already been
denied are particularly disadvantaged as other botanical Pharmafoods and Botanical Claims State
claims are still unregulated and allowed. Equally the of Play
Commission has not yet come up with a proposal for
the nutrient profiles, which should have been the basis
Nathalie Chaze, Deputy Head of Cabinet of Commis-
for the entire regulation. The Health Claims Regulation
sioner Vytenis Andriukaitis, European Commission, ex-
judges on single foods, but it is nonsense to think that
plained that the overall food policy in the EU is under
people eat just one food all the time. She therefore
review, as a number of re-evaluations and REFIT
believes that the Health Claims Regulation was a
(Regulatory Fitness and Performance Programme) exer-
mistake from the very beginning, as to date, 9 years
cises have been launched to assess whether it is fit for
after it came into force, the most important elements
purpose and aspects of the legislation have not been
are still missing.
implemented. This is being carried out not just for the
Health Claims legislation but also the General Food Law
Meanwhile, the Regulation on the provision of
which is celebrating its 15-year anniversary this year
food information to consumers (FIC) (Regulation (EU)
(end of November). We have a good system in place to
No 1169/2011) is implemented, which in her view
ensure food safety, which was why the General Food
makes the health claims regulation superfluous. She
Law was established in the first place, and its not easy
believes that if we want to educate people on how food
and we face regular crises and it is never a finished job,
can contribute to health, we should inform consumers
it is ongoing, she explained. The REFIT exercise also
on a balanced diet and the composition and prepara-
looks at the re-evaluation of the pesticide legislation.
tion of food. This does not mean that the inclusion of
vitamins and minerals should be prohibited, however, if
She acknowledged the challenges faced, particularly in
consumers are better informed, they can use the FIC
recent years, in relation to science, as scientific opinions
Regulation to decide for themselves. Food labelling al-
with an unfavourable outcome were challenged. It is
lows consumers to see immediately if the product is
difficult to take a decision as policy makers, as civil soci-
supplemented with vitamins and minerals as it has to be
ety and stakeholders challenge scientific opinions. In the
included in the ingredients list, and can be added to the
field of food, it is one of the first challenges we are fac-
nutrition declaration, which can act as a marketing in-
ing and we see it in different fields. Another challenge,
strument. Article 7 of the FIC Regulation further protects
she explained, is the evolution in consumer choice.
consumers from misleading information.

In the past, food safety and quality were the main con-
cern. Now, more and more, food is seen as a means for
physical health and no longer just for nutrition. She al-
luded to the Joint Research Centres (JRC) study pub-
lished by the Commission which looks at EU Health and
Nutrition in 2050. The study describes different scenari-
os of where food will go, and one of them is
Pharmafoods. We are seeing this trend more and
more in society, in particular with the growing trends in
obesity, food needs to be healthy and maximise our
healthy life years. There is a huge demand from society
for truth about healthy food. This is why, she explained,
Nathalie Chaze the Health Claims Regulation plays an important role.

It was established to ensure that customers would have

The European Parliament asked to review the Health
information about food which was not misleading and
Claims Regulation in the REFIT procedure. Recent objec-
that health claims were approved after scientific assess-

ment by EFSA. The level of scientific evidence required An important question we are faced with is whether we
to make such claims, however, is quite high. Applying can have different regulatory frameworks if it cannot be
the same scientific evidence requirement for food and clearly defined at EU level, as the purpose of the legisla-
botanicals was therefore extremely challenging for the tion is not to give a competitive advantage to a catego-
Commission as it has a significant impact on the prod- ry of food supplement over another. We need to have a
uct and on the market. In addition, would the EU society consistent and balanced approach.
be ready to accept that the Commission rejects all
health claims on botanicals? Regarding the timelines for the REFIT evaluation, the
Commission is waiting for the contractor to prepare its
The lines are blurred between what constitutes a medi- report by the end of 2017. The draft final report of the
cine and what constitutes a food. She believes the Com- study will be presented to stakeholders at an ad hoc
mission has been lenient when it comes to health working group meeting on nutrition and health claims
claims. Although they have rejected a lot, they have on Friday, 27 October 2017. Results of the evaluation
permitted quite a few. Regarding botanical claims, the are expected for the second quarter of 2018.
Commission is looking for a solution and is aware of the
issue. As society becomes more health conscious, and the
trend towards self-care increases, she remarked that the
She believes that the intention of the Health Claims question of which direction we are going with regard to
Regulation is to provide consumers with accurate infor- food is very timely.
mation. By banning all claims, she believes, an infor-
mation vacuum might be created which needs to be The Assessment of Other Substances
addressed. The Health Claims Regulation does not ad-
Added to Food by EFSA
dress requirements for production, quality and safety
for botanicals to the same extent as their evaluation as a
Camilla Smeraldi, Senior Scientific Officer, in the Food
medicine, and she believes that we should maybe have
Ingredients and Packaging Unit of European Food Safe-
looked beyond health claims for botanicals and that we
ty Authority (EFSA), presented EFSAs role in the safety
stopped short in 2006 when attempts were made to
assessment of certain other substances added to foods.
regulate botanicals.
Annexes I and II of the so-called Fortification Regula-
The Commission is looking in particular at the playing
tion (Regulation (EC) No 1925/2006 on the addition of
field between botanicals and herbal medicines, which
vitamins and minerals and of certain other substances
sometimes contain the same ingredient, or may be clas-
to foods) list vitamins and minerals and their formula-
sified in one Member State as a botanical and in anoth-
tions which may be added to foods. Annex III, which
er as an herbal medicine. These different regulatory
applies to foods in general and food supplements, lists
frameworks can create distortions in terms of the EU
certain other substances whose use in foods is prohibit-
single market.
ed, restricted or under Community scrutiny. Article 8 of
this Regulation forms the legal basis for a safety assess-
ment of certain other substances by EFSA.

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Article 8 procedure

After a safety assessment by EFSA, the Commission, on Article 8 procedure. The ANS panel supports the deci-
the basis of the EFSA opinion, will take a decision to sion-making procedure in the authorisation procedure
restrict the substance by placing it in Part A (prohibited) for new food additives/changes to permitted uses and
or Part B (restricted) of Annex III if a harmful effect on the re-evaluation of permitted additives since 2009. The
health is identified, or in Part C (under Community scru- ANS panel in EFSA also has self-tasked mandates and is
tiny), if scientific uncertainty persists on the identifica- due to publish an opinion on the approach followed for
tion of potential harmful effects on health. the refined exposure assessment as part of the safety
assessment of food additives under re-evaluation. The
She explained that to start an assessment EFSA needs a panel is also in the process of drafting Guidance on the
mandate. In the case of Article 8, procedures carried out Evaluation of Nutrient Sources. With the evaluation of
by EFSA always come from the Commission, either of its nutrient sources there is an overlap with the NDA panel
own initiative or on request from the Member States. In as often it is involved in novel food assessment.
the latter case, the request must contain available and
relevant generally accepted scientific evidence that the
substance is added to food, the amount exceeds what
could be expected in the diet and evidence on its po-
tential risk to the general population.

To start a scientific assessment EFSA always needs a

mandate which contains the question the scientific
opinion needs to answer. Ten scientific panels support
the remit of EFSA. These are composed of independent
experts who evaluate the data (available data is re-
trieved from the literature and calls for data are
launched), provide the scientific assessment and pre-
pare the draft opinion in multidisciplinary working
Camilla Smeraldi

She then described the current structure of EFSA. The However, as of July 2018, all EFSAs scientific panels will
NDA (Panel on Dietetic Products, Nutrition and Aller- be renewed. The ANS panel will be re-established as the
gies) panel is tasked with the evaluation of health panel on Food Additives and Flavourings (FAF), tasked
claims. The Assessment of Nutrient Sources (ANS) panel with the safety assessment of food additives and fla-
is currently tasked with the safety assessment of food vourings. The new panel will hand over responsibility for
additives, nutrient sources and the bioavailability of the the evaluation of nutrient sources and the evaluation of
nutrient from the sources, and safety assessments under Article 8 procedures to the NDA panel, which makes

sense as often Article 8 procedures are a direct follow- for example, or if it can be product specific. Within 4
up of a health claim evaluation. years from the date a substance has been listed in An-
nex III, Part C (under Community scrutiny), the Commis-
EFSA has a limited experience with safety assessments sion must take a decision to either generally allow the
conducted under this regulatory framework. In total, five use of the substance or list it in Annex III, Part A
mandates have been received to date, all related to sub- (prohibited) or B (restricted) as appropriate. This deci-
stances from botanical sources, mainly used as food sion should take into account any further opinion of
supplements ingredients. EFSA based on dossiers submitted by any food business
operators/interested parties.
In August 2012, EFSA received two mandates from the
Commission regarding Yohimbe and Ephedra species EFSA currently has three ongoing mandates. One of
triggered by the Member States, in particular, BfARM, these, relating to Hydroxyanthracene derivatives, was
the Federal Institute for Drugs and Medical Devices in started by the Commission of its own initiative and is a
Germany. As a result of the EFSA scientific assessment, follow-up of an earlier health claim opinion issued by
Yohimbe was placed under Community scrutiny (part C the NDA panel on the substantiation of a health claim
of Annex III) in 2015 and Ephedra was placed in the list related to an improvement of bowel function. Five pos-
of substances which are prohibited (part A of Annex III). sible botanical sources have been identified: Aloe, Rhu-
In the case of Yohimbe, a valid dossier was not received barb, Cascara, Senna and Frangula. The assessment is
so the Commission must take a decision to restrict, pro- ongoing with preliminary conclusions presented to the
hibit or allow Yohimbe by April 2019. ANS Panel in September 2017. An extension of the
deadline was requested from the Commission to allow
For substances placed under scrutiny in Annex III Part C for a call for data. The opinion is to be adopted by the
(i.e. harmful effects are identified but scientific uncer- end of November 2017.
tainty persists) a follow-up mechanism is foreseen by
the legislation. There is a period of 18 months for food The Commission initiated another Article 8 procedure
business operators to submit a follow-up opinion dossi- shortly afterwards, on request from Member States
er to EFSA. The evaluation by EFSA has to be completed (Denmark, Sweden and Norway) following safety con-
9 months from the date of receipt of a valid dossier. So cerns related to hepatotoxicity with Green tea catechins,
far, there has been no experience with the follow-up, if in particular (-)-Epigallocatechin-3-gallate (EGCG). The
the dossier can come from groups of interested parties assessment is ongoing and a draft opinion was dis-

Conference report

cussed by the ANS Panel ad-hoc working group in Sep- monisation among Member States can make enforce-
tember 2017. An extension of the deadline until Q1 ment by the Commission in the area of food supple-
2018 was requested, as the US pharmacopeia is con- ments difficult. In the case of classification, it could take
ducting a similar assessment. years to get the food off the market.

The last mandate received relates to Monacolins in red She pointed out that although vitamins and minerals
yeast rice. The procedure was initiated by the Commis- are harmonised, the maximum amounts are not, which
sion of its own initiative and is a follow-up of a health causes a lot of issues. There is also no harmonisation of
claim issued related to monacolin K from red yeast rice botanicals and other substances, which makes it difficult
and the maintenance of normal blood LDL-cholesterol to enforce. She is also a strong supporter of the Health
concentrations. The assessment is ongoing, and a public Claims Regulation, as the presentation of a product af-
call for data was just launched. Completion of the as- fects whether it is seen as a medicine or not.
sessment is anticipated for February 2018.

Food Supplements and Internet Sales

A View from Austria

Dr Amire Mahmood from the Federal Ministry of

Health, Austria, began by recalling a previous AESGP
conference on the then newly released Food Supple-
ments Directive 2002/46/EC, where she believed maxi-
mum levels of vitamins and minerals would be estab-
lished by 2006. Now in 2017, it is still not harmonised.

As a Member State she supports harmonisation in the

area of food supplements and health claims, which she
Amire Mahmood
can especially appreciate working in the Federal Minis-
try of Health in Austria and hearing the issues in the
As more and more claims are found on the internet ra-
food industry. The main problem with food supple-
ther than on the product, it is not easy for competent
ments, she explained, is classification. The lack of har-

authorities to find these claims. The new Official Con- dedicated to every request for Administrative Assistance
trols Regulation (Regulation (EC) No 2017/625 on offi- and Cooperation which does not present health risks.
cial controls and other official activities performed to The intention was also to signal to food business opera-
ensure the application of food and feed law rules on tors that e-commerce control is taken seriously by the
animal health and welfare, plant health and plant pro- competent authorities and to build experience and ca-
tection products, which replaces the old Regulation (EC) pacity with the enforcement of food law towards inter-
No 2004/882) hands over more power to food authori- net sales of food.
ties and will come into force by the end of 2019.
Each Member State looked at websites which offer
food in their official language. So far no mystery shop-
ping was required. There was a control period and now
the notification period is ongoing. Notifications were
made via RASFF or via AAC (AA). Dr Mahmood hopes
that this co-operation works and finds products which
should be removed from the market so that food busi-
ness operators can be adequately controlled.

Regulatory Gaps and Legal Uncertainty

Speaking from the consumer perspective, Ilaria Passa-

rani, Head of the food and health department, Europe-
an Consumer Organisation (BEUC), opened the discus-
sion with a metaphor of EU society at a crossroads for
many food policies issues. This hesitation, she ex-
plained, is at the expense of consumers rights to infor-
It allows food inspectors from the ministry to perform mation and consumer health and she is looking forward
mystery shopping. Samples can be ordered from food to some action. She explained that while we wait for
business operators by the competent authorities with- decision makers to show us the way forward, consumers
out identifying themselves for the purposes of an offi- remain confused over similar products and are exposed
cial control. The food business operator needs to be to misleading claims and health risks.
informed that such samples have been taken, and must
have the right to a second expert opinion. In the case of
non-compliance there is a possibility for food inspectors
to cease the internet activities of the food business op-
erator for an appropriate period of time.

The European Commission recommendation on a coor-

dinated control plan on internet sales, which came out
in July 2017, asked Member States to look more at bone
and joint health supplements with medicinal claims and
four novel foods are listed as non-authorised: Agmatine
(4-aminobutyl) guanidine sulfate, Acacia rigidula,
Epimedium grandiflorum and Hoodia gordonii. The aim
was to strengthen the cooperation and administrative
assistance between Member States and practise using
RASFF (the Rapid Alert System for Food and Feed) and
AAC (AA) and AAC (FF) for a fast exchange. The AAC
Ilaria Passarani
(Administrative and Assistance Cooperation system) is
an IT system set up for EU countries to exchange data in
a structured manner regarding non-compliance with She then described how consumers may feel confused
food and feed legislation. Since August 2016, the sys- with the example of a botanical regulated as an herbal
tem has been split in two parts: a part dedicated medicinal product and a food supplement. St. Johns
to Food Fraud and the Food Fraud Network, and a part Wort (Hypericium Perfortum), which is sold in Spain as a

Conference report

herbal medicine and in Belgium as a food supplement. times greater than the levels recommended by BfARM).
Both products make slightly different claims. For the The Consumentenbond test used in the Netherlands
herbal medicine it is the systematic treatment of fatigue found that 3 of the 5 food supplements examined con-
and loss of interest, and for the food supplement claim tain much more or much less iodine than the label indi-
it is a balancing effect on mood swings. The herbal cates. Some of these products were withdrawn while
medicine warns against several interactions and side others remain on the market. Establishing maximum
effects while the food supplement does not. This dispar- and minimum limits as well as deviation margins for
ity, she warned, can have an important impact on pa- vitamins and minerals is long overdue, so that consum-
tient safety. Even if botanicals only make minor claims, ers are not exposed to either too low doses or too high
it is vital to guarantee that these claims are justified and doses, she explained.
that these products live up to the promises they make.
She therefore believes botanical claims should be evalu- She believes that more controls are needed for food
ated by EFSA as all other claims, and should not be supplements sold online to protect consumers from
granted special treatment. dangerous products, as information on interactions and
side effects is often not available. The Commission rec-
Regarding the ongoing revision of the Health Claims ommendation on official controls for products sold over
Regulation, the Consumer Association believes that, to the internet is a welcomed step, as RAPID safety alerts
protect consumers from exaggerated and unsubstanti- for food supplements have more than doubled since
ated claims, if there is no evidence, there should be no 2010.
claim. However, if botanical claims are questioned, she
fears that all claims rejected by EFSA under Article 13 As a consumer association, she hopes that decision-
might be challenged, which the Consumer Association makers will find the right direction and be guided by
do not want. key principles, putting consumers safety at the centre:
products should be safe, especially those used for
Commenting on the REFIT evaluation of the Health health, consumers should get value for money and
Claims Regulation, she said we are evaluating some- products should be effective, classification should be
thing that hasnt been implemented and hasnt yet pro- coherent and based on the characteristics of the prod-
duced an impact. She believes this is a dangerous path ucts and rather than the possibility to make health
to take as it could extend to other legislation. claims, consumers should be informed and all claims
should be substantiated by good evidence. This applies
Another pending issue she reflected on is the lack of EU to all consumer products. If the EU wants to reconnect
harmonised maximum levels for vitamins and minerals. with its citizens it needs to act quickly, she said. If we
The Stiftung Warentest test in Germany showed the risk dont act quickly, we risk losing consumer confidence in
of too high doses of vitamins in food supplements (5 these products, and this is no ones interest.

The Real Implications of The New Medical
Session 2
Device Legislation

Moderated by Gesine Meissner, Member, Committee rather than a revolution. It will build on characteristics
on Environment, Public Health and Food Safety (ENVI), of the older system, for example, the central role of no-
European Parliament, and shadow rapporteur for the tified bodies in the certification process and the balance
political group of the liberals during the legislative pro- between post and pre-market controls, while address-
cess for the Medical Devices Regulation (so-called ing the scandals arising in recent years, adapting the
MDR), this session looked at the implications of the rules to technological advances, and thereby increasing
new medical device legislation. Mrs. Meissner remarked patient confidence in the system.
that the legislative process was difficult and alluded to
the challenges ahead with the implementation of the Novelties introduced by the legislation include the pre-
legislation. market control for manufacturers of high risk devices
with the involvement of a pool of experts at EU level.
Another is the enforcement of the criteria for the desig-
nation and oversight of notified bodies. In particular the
new regulation reinforces the joint assessment of noti-
fied bodies, already introduced in 2013, a system
through which experts from Member States and the EU
Commission, jointly assess the competence and perfor-
mance of notified bodies. The medical device regulation
now also covers devices not used for a medical purpose,
which present the same characteristics and have an
analogous profile to an existing medical device, for ex-
ample, contact lenses used for aesthetic purposes. It
will increase transparency through the establishment of
a comprehensive database of the lifecycle of all medical
devices available on the EU market, which will be largely
Gesine Meissner
publicly available. The regulation will also introduce a
stricter regime related to the use of hazardous sub-
Novelties of The New Medical Devices Reg- stances and requirements for an implant card to be giv-
ulation - The Commissions Perspective en to patients containing information about the im-
plant. It will reinforce the rules on clinical evaluations
and investigations, including an EU wide co-ordinated
Carlo Pettinelli, Director, Consumer, Environmental and
procedure for clinical investigations taking place in
Health Technologies, Directorate General Internal Mar-
more than one Member State. It will also improve co-
ket, Industry, Entrepreneurship and SMEs, European
ordination between Member State in the fields of vigi-
Commission, opened the session by acknowledging the
lance and surveillance. Obligations of economic opera-
crucial role of medical devices in self-care and as such
tors have been specified and detailed and the roles and
the sustainability of health systems. He thanked for the
responsibilities of authorised representatives are being
commitment of all stakeholders that as of May 2017,
after 5 challenging years, the EU legislation for Medical
Devices has become law, and the EU now stands at the
In respect of substance based medical devices, he ex-
forefront of innovation and progress in this field in the
plained that they will be subject to a new classification
Rule 21. Rule 21 was introduced to fill a legislative gap.
The old legislation on medical devices adopted 20 years
He firmly believes that the legislator has managed to
ago was not conceived with these products in mind.
stick to the principles of balance and proportionality
Consequently, they generally fell in class I without a
and while the regulation will allow a uniform application
consideration of their risk. This was later unanimously
of its rules, the system will undergo a deep evolution

Conference report

seen as problematic, as some of these products are of- and the Eudamed database since last year. On the sec-
ten used by vulnerable patient groups and are available ond question, he highlighted that not only does the
without prescription. The new legislation ensures that Better Regulation framework give stakeholders an in-
the safety of these products is appropriately checked by creased opportunity to comment, the new legislation
notified bodies. However, the strictest conformity as- assigns a key role to stakeholders in expert groups.
sessment procedure is only reserved for those products Commission communication with stakeholders has al-
which are systemically absorbed. He believes that, in ready taken place. The Commission and the Competent
respect of substance-based devices, they succeeded in Authority for Medical Devices (CAMD) organised on the
negotiating a proportionate and risk-based approach. 9th March 2016 the first stakeholder workshop with an
exchange of views on the workplan for the coming
years. The next workshop on 18 October 2017 will final-
ise the roadmap for the new medical device regulation.
The roadmap will set the timing and framework of fu-
ture deliverables for the Commission and Competent
Authorities mainly interpretative and operational guid-
ance for the medical devices regulation.

In light of this, he is confident that the real implications

offer concrete opportunities for EU medical devices pa-
tients and the health care system as a whole.

He remarked that the EU medical device regulation has

inspired other countries and a few days ago at the Inter-
Carlo Pettinelli national Medical Devices Forum (IMDF), the Australian
authorities declared that they will align their legislation
In the context of the qualification and classification of to match that of the EU. He is convinced that by work-
borderlines, there will be more legroom to take the ing together we can make a successful transition and
Commissions decision on the regulatory status of prod- further develop this important sector.
ucts, as the Commission will now be able to initiate a
decision procedure of its own initiative. The Key Constraints to Implementation -
A Competent Authority View
In co-operation with the future Medical Device Co-
ordination group (MDCG), the Commission intends to
John Wilkinson, Director of Medical Devices, Medicines
take initiative whenever needed to ensure that the inter-
and Healthcare products Regulatory Agency (MHRA),
nal market functions in an efficient manner and that
United Kingdom, stressed that the implementation of
patients rights are guaranteed. At the same time, stake-
the MDR should be consistent and fair which was a
holders are always in a position to input their views and
problem with the old directives.

The effective and timely implementation of the legisla-

tion is crucial to ensure that expectations are properly
fulfilled and is a challenge which lies ahead. The Com-
mission is keen to ensure that the new system brings
added value for all stakeholders.

Anticipating questions AESGP has on whether the Com-

mission has enough resources to make all this happen
and to what extent stakeholders will be in a position to
inform the implementation process, he explained that
the Commission intends to allocate sufficient staff to
this task. The Commission services have already started
work on the secondary legislation, relevant guidance
John Wilkinson

New responsibilities have been given to competent au- applicable and Member States have less latitude to in-
thorities. New products such as cosmetics and software terpret things. Eudamed is a critical building block of
will now fall under the scope of the medical devices the system. If Eudamed is late, he stressed, there need
regulation, which will present a challenge for everyone to be provisions on how this can be handled.
in the system. The new legislation also calls for more
specific responsibility from actors in the supply chain, Two groups are underpinning the work on implementa-
which will present some challenges because this supply tion of the regulation and dealing with these con-
chain is global. How were going to manage that sup- straints: the implementation Task force, an ad hoc
ply chain, he added is going to be critical going for- group recently reconstituted looking at what needs to
ward. Dealing with borderline substances and combi- be done, and the transition subgroup. Work will also
nation products in a practical and timely way is also cru- need to be done by expert groups in different areas.
cial going forward. The transition subgroup mainly consists of regulators
and lawyers looking at interpretive legal issues with the
He explained that the Competent Authorities for Medi- transitional provisions.
cal Devices (CAMD) network and the Commission will
start work over the next 18 months to map out the im- He explained that we are transitioning from an old to
plications of the implementation process and the EU new governance structure (the CAMD to the Medical
work plans which will extend over several years. He re- Device Coordination Group (MDCG)). The MDCG has a
minded that the roadmap will be revealed on the 18th of broader role and is currently looking to reduce duplica-
October at the next stakeholder meeting. tion in the roles.

The MHRA has also been mapping the implementation On classifications under the new regulation, he ex-
of the MDR, which is a lot of work for national authori- plained that the focus should not be on up or down
ties. There are a number of key constraints to the imple- classifications, but on the evidence to support clinical
mentation of the Medical Devices Regulation, such as claims. In respect of substance-based medical devices,
the dual regulatory system during the transition period, he too believes that the old legislation was inadequate.
and how people perceive the new CE mark versus the On clinical evaluations he stressed the importance of
old CE mark. The whole system will be underpinned by evidence to support risk assessments.
guidance and it will evolve. The regulations are directly

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In terms of challenges ahead, he explained that it is characteristics which make it unique. He stressed that
about getting clarity through the legal text to give eco- this is particularly relevant for medical devices made of
nomic operators clarity going forward. complex natural substances, whose composition cannot
be generalized and linked to homogeneous product
MDR Implementation and Substance-Based categories. He believes that the application of these two
Medical Devices criteria, combined with a constructive discussion be-
tween European and national regulatory authorities,
notified bodies, industrial associations and companies,
Emiliano Giovagnoni, Regulatory Affairs Director, Abo-
will allow us to face effectively the main criticalities of
ca, presented the industrys perspective on the imple-
the new regulation.
mentation of the MDR. Now that the regulatory frame-
work for medical devices has been defined, he believes
There are many aspects of the new regulation that will
it is important to establish implementation rules able to
have a significant impact on industry and that must be
welcome the innovative character of substance-based
taken into consideration. These include the definition
medical devices.
(article 2) of a medical device, the classification Rule 21
and defining the concept of absorption, clinical prod-
We need to define the rules of the game, in order to
uct evaluations and the role of notified bodies. The solu-
implement the provisions of the new regulation proper-
tion, he explained, can be found by adopting a
ly, he explained. To do this, two main criteria need to
harmonized European interpretative system based on a
be taken into account: a European harmonized interpre-
"case by case" evaluation.
tative system specifically designed for substance-based
medical devices, and case by case evaluations. We
A principal intended action which is achieved by phar-
need a regulatory approach specifically developed for
macological, immunological or metabolic means distin-
substance-based medical devices he explained, which
guishes a medicinal product from a medical device. He
takes into consideration the differences with medicinal
explained that up to now, an approach by exclusion
products. This, he explained can be achieved with a
has usually been followed at regulatory level and a
systematic revision of the guidance documents
product is generally classified as a medical device only
(Meddev, Common specifications etc.). Once the gen-
when there are no medicinal products already regis-
eral interpretative context has been defined, it is neces-
tered, regardless of whether its mechanism of action is
sary that each product is evaluated according to its

by pharmacological, immunological or metabolic mechanism of action, a colligative property which de-
means. He therefore believes it is necessary to reassess pends on the concentration of solute rather than the
all the mechanisms of actions and to assign each of structure of the molecule. As there is no receptor-ligand
them either to the category of medicinal products or to interaction the mechanism of action should be regarded
the category of substance-based devices, based on sol- as a medicinal product. The definition of
id scientific data and regardless of their historical classi- pharmacological means is crucial for the medical de-
fication. This would ensure a harmonised EU approach, vices sector. Meddev 2.1 provides a starting point, but
and avoid inverse shopping legislation, and attempts he believes it needs to evolve, and not introduce the
to support historical classifications. concept of indirect pharmacological action.

Rule 21 places absorption at the centre of the classifica-

tion system. When absorption is relevant for the intend-
ed purpose the classification is clear. However, all sub-
stance based medical devices, are somehow absorbed
by the human body. In the absence of a clear criterion, a
product containing substances generally recognized as
safe and other active substances absorbed in concentra-
tions not relevant for risk assessment would be classi-
fied in class III without any justification. He believes that
absorption should justify class III only when the sub-
stances absorbed are relevant for the risk assessment.

Aboca proposes for products containing natural sub-

Emiliano Giovagnoni stances to apply metabolomics techniques to evaluate
the extent of absorption. Manufacturers would be able
He gave examples of inverse shopping legislation such to assess on a case-by-case basis, if the substances is
as an osmotic/ bulk-forming mechanisms of action for absorbed in concentrations relevant for risk assessment,
laxatives, a mucoprotective action for cough syrups and and then whether the extent of absorption is such that
a bacterial anti-adhesion mechanism of action in prod- classification of the product in Class III is required. Oth-
ucts for cystitis. In Abocas view antacids should be con- erwise, it should fall into Class IIb.
sidered as medical devices. Of interest is the osmotic

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Regarding the role of notified bodies, it is necessary to

ensure an efficient system of notified bodies able to
manage the huge number of requests they will receive,
within the timeline of the transitional period, given that
substance-based medical devices currently classified as
class I will seek Notified body certification, and a gen-
eral upgrade of the risk class is foreseen for many sub-
stance-based medical devices. And in Italy alone, more
than 2,000 substance-based medical devices are cur-
rently on the market. A European system of notified
bodies highly specialized in the evaluation of substance-
based medical devices and able to ensure a smooth
transition from the current system to the new one is
critical, he explained.
Bettina Funke

Clinical Evaluations and the Equivalence

Approach She explained that equivalence to another similar device
can be demonstrated from the scientific literature by
taking into consideration the technical, biological or
Bettina Funke, Head of Medical Devices, Scientific &
clinical characteristics of the product.
Regulatory Affairs, R&D Consumer Health Care, Merz
Consumer Care GmbH, presented the industrys view on
Technical equivalence, she explained is the most fea-
the equivalence approach for clinical evaluations. The
sible to demonstrate especially when the device has a
new medical devices regulation introduces stricter re-
similar design, similar conditions of use, similar specifi-
quirements for clinical evaluations. In that context, clini-
cations and properties and similar principles of opera-
cal data, defined under article 2, as information con-
tion and performance requirements. Next would be bio-
cerning the safety and performance of medical devices,
logical equivalence; having the same materials or sub-
can be sourced either from the scientific literature on
stances in contact with the same human tissues or body
similar devices, clinical investigations or post market
fluids for a similar kind and duration of contact and sim-

ilar release characteristics. Last would be the clinical more meaningful. Moreover, if equivalence cannot be
characteristics; having the same clinical conditions or established a huge number of additional clinical trials
purpose, severity and stage of disease, same site in the will be required.
body and similar population. There is also a require-
ment for manufacturers to have sufficient levels of ac- She then presented the challenges with performing clin-
cess to the data relating to devices with which they are ical trials. You need to convince an ethical commission
claiming equivalence in order to justify their claims. about the need for a trial for a change in substance hav-
However, what is deemed sufficient needs to be clari- ing no impact on the principal mode of action or for a
fied. longstanding product, and this could be judged as a
repetition of an already conducted trial which would be
She then gave examples of possible outcomes when the unethical. Financial concerns are also an issue. We
equivalence approach is interpreted too strictly. One may lose a number of good products since high invest-
example was of a nasal spray made from seawater, ment in clinical trials may not be commercially viable for
where the source of the seawater in the formula was each individual product. The remaining transition peri-
changed. Another was a simethicone preparation, where od lasts for only two and a half years from now which is
a flavouring excipient was changed. Although these extremely challenging for all parties to handle this huge
seem like minor changes the equivalence of both the amount of trials. Substance based medical devices are
nasal spray and the simethicone preparation could be at risk of requiring new clinical trials for formal reasons,
questioned. However, she believes this general view she explained and although the legal manufacturer
doesnt really contribute to the safety and performance wants to comply with the new legislation, these safe and
of substance based medical devices. She believes that effective products may disappear from the market.
instead, a thorough case by case evaluation would be

Fostering Market Access for Substance-

Session 3
Based Medical Devices

Moderated by Maud Perrudin, Legal and Regulatory

Affairs Manager, AESGP, this session explored the key
market access issues for manufacturers of substance
based medical devices and the views of representatives
from different notified bodies.

Regulatory Challenges for Notified Bodies

and Market Implications

Roberta Marcoaldi, Director of the Notified Body 0373

-Istituto Superiore di Sanit (ISS), Italy, presented the
challenges of the new Medical Devices Regulation for Roberta Marcoaldi
notified bodies. She explained that in the last few years
the legislation for the medical devices sector has been
The Regulation 920/2013 has involved a re-
subject to a long and complex review process. The revi-
accreditation process of Notified Bodies which has not
sion has become necessary to ensure a high level of
yet been concluded. Some Notified Bodies have been
patient and user health protection. In 2013 the Commis-
unable to demonstrate their ability to respect the new
sion implementing Regulation on the designation and
requirements and therefore the previous designation
the supervision of notified bodies under the Medical
obtained in accordance with the directive 93/42/EEC
Devices Directives was published which proposed new
was withdrawn. This has led to market problems as sev-
requirements for Notified Bodies.
eral manufacturers have been forced, within a relatively

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short time, to identify an alternative Notified Body for ble for notified body, assessment by the Commission
the CE Certification of medical devices. and the Medical Device Expert Group, appointment of
the joint assessment, audit on site (on site assessment
In the Regulation 920/2013 some issues concerning the of applicant body), follow up activities (report of joint
role and obligations of Notified Bodies were in fact an- assessment and authority responsible for notified body).
ticipated, and include: the qualification of the personnel, Then the MDCG will deliver its recommendation and a
Quality management system (QMS), the definition of decision will be taken on the designation of Notified
conformity assessment procedures, demonstration of Body. The re-accreditation process will also be followed
the availability of personnel for clinical evaluations, by the notification of the designation (which might take
deepening of the qualification and classification assess- another 3 6 months).
ment procedures and deepening of the clinical data
assessment procedures including the Post-Market Clini- She believes that the harmonization of conformity as-
cal Follow up (PMCF). sessment procedures has not yet been achieved, in par-
ticular for: unannounced audits (are notified bodies
The entry into force of the new Medical Devices Regula- forced to submit a three year plan and not five as per
tion (MDR 2017/745) emphasizes and shows more strin- the MDR?), clinical evaluations (are notified bodies
gent requirements for notified bodies, manufacturers, forced to apply the guideline that underlines the princi-
the technical documentation produced by manufactur- ple of equivalence; MEDDEV 2.7.1 rev. 4?), personnel for
ers, Post-Market Surveillance (PMS) and Post-Market clinical evaluation (are notified bodies forced to demon-
Clinical Follow up (PMCF). New classification rules have strate a clinical expertise for personnel that carry out the
been introduced, such as the new approach for sub- clinical evaluation?) and medical devices containing me-
stance-based medical devices and medical devices dicinal substances .
which contain medicinal substances. The Medical Device
Coordination Group (MDCG) now also plays a role in The MDR 2017/745 establishes the qualification of sub-
the conformity assessment process and re-accreditation stance-based products and defines a special classifica-
process of notified bodies. tion rule: 21. MDR requirements also define a more
stringent approach to assess such medical devices. This
All Notified Bodies must be re-accredited in order to represents a new challenge for Manufacturers and Noti-
carry out certification activities in accordance with the fied Bodies. Substance-based medical devices will no
MDR. The timeline for the application of the regulation longer be classified in class I. This will mean an in-
is 26 May 2020. All Notified Bodies will have to submit creasing number of medical devices requiring the evalu-
their application for the new designation in the coming ation of a Notified Body, and the development of spe-
months. She explained that the Italian competent Au- cific know-how will be necessary, in particular for Noti-
thority has already asked the Italian Notified Bodies to fied Bodies.
express their intention to re-designate and to indicate
the period during which the application will be submit- Rule 21 introduced the concept of substances absorp-
ted. tion. In this respect, she believes it is necessary to define
a correct interpretation of rule 21 and understand the
A draft list of NBOG codes (types of devices for the pur- term absorption of substances, as the absorption of
pose of specifying the scope of the designation under substances can determine the classification of medical
the Regulation (EU) 2017/745) has been published. A devices.
draft application form (for designation as notified body
under the Regulation (EU) 2017/745) is expected to be In addition, the quality and safety of devices that are
published by the end of November 2017. Then the Noti- composed of substances or of combinations of sub-
fied Bodies will be able to submit their application for stances that are intended to be introduced into the hu-
designation by December 2017 / January 2018. man body via a body orifice or applied to the skin and
that are absorbed by, or locally dispersed in, the human
We are very concerned because the re-accreditation body, shall be verified where applicable and only in re-
process will be very articulate and surely quite long (up spect of the requirements not covered by this Regula-
to 20-24 months) for assessment purposes, because a tion, in accordance with the relevant requirements laid
number of different assessments steps are required: a down in Annex I to Directive 2001/83/EC for the evalua-
preliminary assessment report of the authority responsi- tion of absorption, distribution, metabolism, excretion,

local tolerance, toxicity, interaction with other devices, addressed in the manufacturer's post-market surveil-
medicinal products or other substances and potential lance plan.
for adverse reactions.. The notified body shall seek a
scientific opinion from one of the competent authorities Rule 14 on medical devices incorporating a medicinal
designated by the Member States in accordance with substance requires that the quality, safety and useful-
Directive 2001/83/EC or from the EMA on the compli- ness of the substance be verified with the methods
ance of the device with the relevant requirements laid specified in Annex I to Directive 2001/83/EC. Notified
down in Annex I to Directive 2001/83/EC. The opinion of bodies must then verify the usefulness of the medicinal
the medicinal products authority consulted shall be substance and seek a scientific opinion from a compe-
drawn up within 150 days of receipt of all the necessary tent authority or EMA on the quality and safety of the
documentation. The notified body then has to consider substance including the benefit or risk of the incorpora-
the views expressed in the scientific opinion. Manufac- tion of the substance into the device. Under the old
turers will therefore have to provide documentary evi- Medical Device Directive, the notified body could take
dence in the product technical documentation for Sub- the updated scientific opinion into account in reconsid-
stance based medical devices. ering its assessment of the conformity assessment pro-
cedure. Under the new medical device regulation, the
All manufacturers are also required to establish and up- notified body cannot deliver the certificate if the scien-
date a clinical evaluation plan to demonstrate conformi- tific opinion is unfavourable and shall convey its final
ty with safety and performance requirements. Clinical decision to the medicinal products authority consulted.
evaluations may be based on clinical data from an
equivalent medical device. However, the demonstra- She concluded by describing how Notified Body 0373
tion of equivalence is very difficult for manufacturers. are preparing themselves for the application of the
MDR. We will submit our application in the first three
As a notified body, she plans to support the manufac- months of next year, then we will carry out the new
turer during the transitional period. The manufacturer is qualification of personnel taking into account new Noti-
also required to proactively collect and evaluate clinical fied Body Operations Group (NBOG). We will also review
data (Post-market Clinical Follow up (PMCF)) to confirm our quality management system and conformity assess-
the safety and performance of the medical device ment procedures. The certification process will also be
throughout its expected lifetime. It is a continuous pro- reviewed considering the change of the MDR (role of
cess which updates the clinical evaluation and should be Medical Device Expert Group, new consultation proce-

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dures with the competent authority for medicinal prod- plies from May the 26th 2020. Finally, the co-ordinated
ucts). Notified Body 0373 will also organize information assessment procedure on clinical investigations shall
and training events for manufacturers. apply from May the 26th 2027.

On the next steps forward, she explained that there The labelling system and whether this will be similar to
should be discussions with the authority responsible for the FDA approach has yet to be defined. UDI (Unique
Notified Bodies on a harmonised approach to imple- Device Identification system) is a costly process. he ex-
mentation. Updates should be shared between the No- plained, We need to implement an acceptable model
tified Bodies and manufacturers to foster closer collabo- and in the regulatory world there isnt enough time to
ration, and discussions at European level (Medical De- do this.
vice Coordination Group, common specifications, imple-
menting acts) should be followed. Consultancy services cannot be offered by notified bod-
ies but TV SD can do mock reviews and offer Gap
Getting Ready for The New Medical Device analysis services. Ultimately though, it is up to industry
Regulation to fill those gaps. In-house trainings offered by TV
SD are generic and cant be tailored for companies.
TV SD also organise workshops and throughout the
transition period they anticipate a high demand for clin-
ical workshops. They can also offer mock audits, clinical
audits etc. They can review the manufacturers clinical
evaluation report, technical documentation, Periodic
Safety Update Reports (PSURS), and they will consider
justifications for not doing a PMCF (Post Market Clinical

He indicated that TV SD is looking forward to the

joint audits by the competent authorities. An uncertain-
ty that remains is whether notified bodies can cope with
the flood of applications. When will notified bodies be
appointed? All in May of 2020, or will it be a staggered
appointment? The MDR is untested so some changes
Jeff Vest can be expected from unintended consequences or in-
terpretations of the legislation. There are still uncertain-
ties remaining relating to UDI, and common specifica-
Jeff Vest, Principal Scientist at TV SD UK, a notified
tions (which have not yet been published).. There are a
body in Germany, began his presentation by giving an
number of key elements that are still missing, he ex-
overview of the timelines of the MDR since the Commis-
plained. He concluded by inviting industry to discuss
sion consultation on the medical devices framework in
updates and meet early with their notified body, so they
2008. Eudamed will need to be functional by March
can advise manufacturers on what needs to be done to
2020. There are confidentiality requirements which ap-
meet the requirements of the MDR.
ply by May of 2018. A lot of manufacturers dont have
the information to meet the MDR. Some class 1 medical
devices will be up-classified. Annex 4 of the Active Im- The Medical Device Regulation and The
plantable Medical Devices Directive (AIMDD) and Annex Uncertainties That Lie Ahead
4 of the Medical Devices Directive (MDD) (for the self-
certification by manufacturers) will become void by 27 Jrg Wilke, from Zertifizerungsgesellschaft fur Mediz-
May 2022. Certificates issued from May 25 2017 shall inproduckte Europa (ECM), opened his presentation
become void at latest on 27 May 2024, although devices with an introduction of his notified body, CE 0481. ECM
may continue to be made available or put into service 0481 is a notified body under the Medical Devices Di-
until the 27th May 2025. From May 2020, there should rective (MDD) since 1995. They lack laboratory capaci-
be no significant changes in the design and intended ties and focus on quality assurance and access. Their
purpose of the device. The reporting of serious adverse scope is limited to mainly non-active medical devices
events and device deficiencies as per the MDR also ap- covering sterile products, animal tissue products and

pharmaceutical active substances. They have experience Rule 14 refers to medicinal substances with an ancillary
with substance based medical devices. They are the action to a medical device but have no clear action on
third notified body to undergo joint assessments. the human body. The rule has led to discussions over
whether the function as a preservative would affect its
He explained that notified bodies are facing an increas- classification. Clarification is also required on whether
ing number of applications due to the decreasing num- rule 19 for nanomaterials is based on the nanomaterial
ber of notified bodies and reclassification due to the or its intended use.
new MDR. In this respect, he welcomed input from in-
dustry. He then described the extent of assessment ac-
tivities carried out by the notified body. There are audit
activities at the premises of the legal manufacturer and
critical suppliers, if necessary, and due to the reclassifi-
cation there will be increased technical file assessments.
A scrutiny and consultation process is now required de-
pending on the nature and classification of the medical
device. Physical product testing during notified body
audits is required, and for certain products there are
periodic review obligations, not covered by the current
legislative framework. All classes apart from sterile class
I or class I a measuring function will require technical file
assessment activities. These are case driven for class III, Jrg Wilke

but for the other classes it will be based on a repre-

sentative sample. However, currently there are no crite- For rule 21 on substance-based medical devices, does it
ria in the MDR of what a representative sample means. apply to the all substances or those achieving the princi-
The NBOG guidance for audits and testing of repre- pal intended action of the product? There is no defini-
sentative samples will no longer be applicable, and tion of substance in the medical device legislation, and
there may be a potential implementing act by the Com- the legislation doesnt refer to definitions in the legisla-
mission concerning the legal requirements for the test- tion for pharmaceutical products. In respect of Rule 21,
ing of samples. there are different perspectives on what is inside the
body. From a biological perspective, he added the
stomach is outside the body. Moreover, absorption re-
quires crossing a barrier to be distributed locally or sys-
temically-therefore the terms locally dispersed and sys-
temically absorbed need to be clarified and are mislead-

He stressed that requirements/guidance is required for

the new classification rules, which the current guidance
doesnt address. At national level, NAKI in Germany, a
co-ordination group has been established located at the
ministry of health, to address these questions. They are
mirroring the competent authority meetings quite well,
and some of its subgroups might be present in the
forthcoming Medical Device Co-ordination Group
(MDCG) which has not been established yet. We need
He explained that clarity is needed for the classification more consensus at EU wide level to allow a homoge-
rule 14 for medical devices with medical substances an- nous interpretation of fundamental questions so that
cillary to the device, replacing the current rule 13, rule manufacturers can apply properly the classification rules
19 for nanomaterials and rule 21 on substance-based and notified bodies can check these procedures.
medical devices.

Conference report

A Business Perspective to Foster Market product. He asked what the sense of this reclassification
Access for Substance-Based Medical Devices was and whether there had been an impact analysis.
Indicating that his company had carried out its own im-
Maikel Hendriks, CEO of Medical Brands, began by pact assessment, he presented the results that a third of
giving an overview of the history of his company, look- OTC medical devices on the EU market could be subject
ing at dental products before moving to the self-care to such reclassification.
sector. Their product portfolio includes feminine prod-
ucts, cough and cold products, footcare etc. and many
different formulations are marketed. Although their first
product Freeze off your Wart was seen as a medical
device by notified bodies and the competent authority,
when it came to market, concerns were raised by the
competent authority because it involved bringing home
treatment people received at the doctor. He firmly be-
lieves that innovation should come before regulation.
He alluded to the blue guide book which was created to
remove technical barriers to EU trade and to enable the
free movement of safe goods. He now believes that
technical barriers to innovation, particularly in self-care Maikel Hendriks
are being created.

Today healthcare is moving closer to the user with mo- Eudamed, the lack of guidance and clinical equivalence
bile apps, the internet, on-line pharmacies, wearables are issues which industry faces going forward. On Noti-
etc. which will lead to less interaction with GPs and con- fied bodies, he explained that we now have 58 notified
venience for products. bodies; when we started, there were 85. In the mean-
time, 16 were withdrawn, 9 expired and 2 were suspend-
Regarding substance-based medical devices, although a ed. Further reduction can be expected with the designa-
physical mode of action was described for Simethicone tion procedure. After discussions with the Commis-
in the reputed opinion by the competent authority, the sion, the first notified body will set the standard and
product was subsequently classified as a medicinal there is a risk that other notified bodies will not pass
The first MDR audits start in May 2020.

He also alluded to the change in the role of the author- up-classification to class III (including new clinical inves-
ised representative from a mailbox function to responsi- tigations). In this regard, she believes that reclassifica-
bility for parts of the manufacturers dossier. On adver- tion should start with a case by case assessment of all
tising, Neprofarm, the self-care association in the Neth- the characteristics of the product. She believes medical
erlands, have developed an advertising code of conduct devices should be regarded holistically, and should they
for medical devices, which, through the work of PAGB, contain substances known to have pharmacological,
will be mutually recognised by the UK. immunological and metabolic properties, the only way
to rule out the medical device classification is to scien-
Authorities should go through the manufacturers dos- tifically establish that the substances do exert such
sier, rather than group products based on opinions from properties in the product as formulated and that such
EMA. He calls for case-by-case reviews of products. properties plays a role in achieving the principal intend-
This will allow self-care to grow, and allow innovative ed action of the product. Core to the business of AESGP,
products to remain on the market. Otherwise, he ex- is proper definitions of pharmacological, immunological
plained, we can create a road-block if we see patients as and metabolic means which is still on the Commissions
incapable of managing their own health. agenda.

AESGPs Priorities and Ongoing Work The so-called rule of doubt set in Article 2.2 of the Me-
dicinal Products Directive 2001/83 applies, provided
that the concerned product meets both definitions of a
Maud Perrudin, Legal and Regulatory Affairs Manager
medicinal product and of medical devices, and results in
at AESGP, presented AESGP priorities with the imple-
the products classification under the medicinal prod-
mentation of new Medical Devices Regulation. The leg-
ucts directive. Oftentimes, she remarked, if a product
islation is a great achievement, she remarked however,
looks like a medicinal product it is classified as such.
the implementation will be a challenge. We are a sci-
When there is certainty that the product is classified as a
ence based industry, she explained, and hopes that the
medicine in the first place, she believes that national
implementation will be science based. In implementing
authorities must still demonstrate scientifically that the
the text, she calls for transparency and a proportionate
product is medicinal by function (which means that it
and uniform approach. AESGPs key priorities include
achieves its action by pharmacological, immunological
transitional measures, the regulatory status of products,
or metabolic means in line with the Hecht Pharma Court
the quality and safety evaluation of substance based
Case, C-140/07, 29). Therefore, proper definitions of
medical devices, and the resource/capacity of notified
pharmacological, immunological or metabolic means
are critical.

She highlighted the issues with determining regulatory

status under the medical devices regulation, such as the
transparency of the Helsinki procedure, which is mainly
dedicated to the national competent authorities with
input from stakeholders far too late in the process. She
is hoping this will improve under the new legislation,
and that AESGP can provide data before a classification
decision is taken. Although Article 4 under the MDR will
be useful to clarify the regulatory status of Medical de-
vices, she calls for a clarification of the consultative role
of EMA, EFSA and ECHA in the determination of the
products regulatory status, the proper involvement of
notified bodies and concerned manufacturers at an ear-
ly stage and a call for data on a category of products
Maud Perrudin published on the Commission website prior to the
launch of the procedure.
A number of Class I devices will be up-classified to
In respect of substance-based medical devices, she indi-
class IIb or from class IIb to class III and there will be
cated that AESGP is doing its homework developing
many new requirements to comply with notably for the

Conference report

guidance on the implementation of Rule 21, including a Referring to the previous presentations, she highlighted
decision tree to help manufacturers in borderline cases the concern of the self-care industry regarding contin-
also with Rules 4, 5 and 19. For quality and safety evalu- gencies with the notified body designation process and
ations, she stressed that concept of generally consid- their capacity to meet the new requirements of the reg-
ered as low-risk should apply to substances with a long ulation. She believes that we should organise collabora-
history of safe use (e.g. as foodstuffs) or that have been tion with Notified Bodies and foster dialogue with na-
scientifically reviewed by European scientific bodies/ tional competent authorities and Commission to devel-
committees. op guidance for Notified Bodies and authorities and
share good practices and expertise. AESGP is happy to
The implementation of Rule 21 should be proportion- share its experience and knowledge with notified bodies
ate and risk-based. She stressed that the classification and competent authorities.
must always be justified by the intended purpose and
the inherent risk. The interpretation of Rule 21 also She concluded by emphasising that the implementation
needs to take into account the various linguistic ver- needs to make the MDR and its Rule 21 useful in order
sions and the overall context of the medical device reg- to achieve its objectives.

Creating a Proportionate Regulatory
Session 4
Environment for Herbal Medicinal Products

Herbal Medicines Are Widely Appreciated Challenges With Traditional Use Registra-
By European Citizens tions

Karin Kadenbach, Member of the European Parliament Agns Mathieu-Mendes, Deputy Head of Unit, Direc-
Committee for environment, public health and food torate Health and Food Safety, European Commission,
safety (ENVI) (MEP) since 2009, presented her views on shared her reflections on the challenges with traditional
herbal medicinal products in a video message. Herbal use registrations for Herbal Medicinal Products
medicines are widely appreciated by European citizens, (THMPs) Herbal medicines can be authorised on the
she explained. 80% of the population have used herbal basis of a full marketing authorisation application, a bib-
medicines, according to various surveys. The European liographic one or registered on the basis of safety and
Parliament was instrumental in the establishment of the plausible level of efficacy attested by a long history of
Herbal Medicinal Products Committee (HMPC) at the use (30 years including 15 years in the EU) under the
European Medicines Agency (EMA), as part of the Di- Traditional Herbal Medicinal products Directive
rective on Traditional Herbal Medicinal products adopt- 2004/24/EC. The Commission endorses the EMA scien-
ed in 2004, she explained. Since then the committee tific assessment with regard to the list of herbal sub-
has delivered notable results, in particular with regard to stances, preparations and combinations thereof for use
establishing monographs for herbal medicinal plants, in traditional herbal medicinal products (Commission
benefiting both patients and manufacturers. She be- Decision 2008/911/EC). The list has recently been en-
lieves that the work of the HMPC will be important in riched with two new list entries: Sideritis herba and Va-
the future, in light of the interest of European citizens in lerianae radix.
these products. She also hopes that the work of the
HMPC will not be negatively affected by Brexit and the
relocation of the EMA. Manufacturers of herbal medi-
cines operate in a competitive environment, and many
products have a lower turnover rate and higher admin-
istrative costs than comparable products. She concluded
by welcoming the timely discussions on creating a pro-
portionate regulatory environment for herbal medicinal

Agns Mathieu-Mendes

Herbal products can be marketed as medicine or food

and the responsibility of the classification lies with
Member States based on the presentation and claimed
effect. This has led to disparity at national level with the
uptake of the traditional use registration scheme. On
this note, she referred to the on-going REFIT evaluation
for the Regulation on health claims legislation; the out-
come of which is needed before to take any steps to-
wards a potential change of the herbal legislation which
Karin Kadenbach
is for the moment seen as fit for purpose.

Conference report

Traditional and Herbal Medicinal Products:

Harmonisation and Globalisation

The work of the EMA Committee on Herbal medicinal

products was illustrated by Werner Knss, Head of Di-
vision, complementary and Alternative Medicines and
Traditional medicines, Federal Institute for Drugs and
Medical Devices (BfArM) as well previous Chairman of
the EMA Committee for Herbal Medicinal Products
(HMPC). One thousand six hundred registrations were
granted over the past years but recently a couple of
new herbal medicinal products were authorised based
on a full Marketing Authorisation Application (MAA):
Episalvan through the centralised procedure and a
green tea extract (Veregen) and Cannabis extract via the
decentralised procedure (DCP). The outputs of the
HMPC fostered harmonisation and mutual understand-
ing of authorities paving the ways to these DCP and Werner Knss
centralised authorisations.

The International Regulatory Cooperation for Herbal

Global harmonisation is also key for companies which
Medicines (IRCH) now under the harbour of WHO; has
seek to export due to the diversity of the regulatory
been an important step towards promotion of best reg-
frameworks across the world. The EMA released a Ques-
ulatory practices on herbal medicines, although it will
tion and Answer document for companies outside the
take some time to develop this platform and find ways
EU want to meet EU regulatory requirements for
how to converge the different regulatory systems.
(traditional) herbal medicinal products.

Contribution of The European Pharmaco- for the determination of one or more markers and the
poeia to A Proportionate Regulatory Envi- possibility to use reagents instead of reference stand-
ronment for Herbal Medicinal Products
She also addressed the very controversial issue of pyr-
After the safety and efficacy pillars addressed by the
rolizidine alkaloids (PAs) contamination detected in
previous speakers, Susanne Keitel, Director, European
herbal medicinal products and food. PAs have been
Directorate for the Quality of Medicines & Healthcare
isolated from 350 plant species, including a number of
(EDQM), addressed the quality one and the important
weeds. According to HMPC investigations the problem
role the European Pharmacopoeia and its general chap-
cannot be solved by simply focusing on Good Agricul-
ter and monographs play in that regard.
tural and Collection Practices. EDQM has been given a
mandate to draft a general methods chapter in the field
of pyrrolizidine alkaloids, and maintain a list of PAs
which may be covered by the general chapter.

The Views of Industry on Herbal Medicinal


Finally the views of the herbal medicinal products indus-

try were presented by Christelle Anquez-Traxler, Reg-
ulatory and Scientific Affairs Manager, AESGP, who
highlighted that the Directive 2004/24/EC and the crea-
tion of the HMPC within the EMA were milestones in the
regulatory system for herbals. The EU herbal mono-
graphs foster harmonisation and facilitate registrations.
Susanne Keitel
However, industry would like an increased acceptance
of well-established use and paediatric use indications in
There are 6 general monographs and 294 individual
EU monographs and more entries making it to the list.
monographs dedicated to herbals. The EDQM has also a
The threshold for acceptable genotoxicity data should
number of specific monographs dedicated to Tradition-
not become so high that no further list entries can be
al Chinese Medicine (TCM) to prevent severe quality
finalised. In respect of paediatric use indications, paedi-
issues (false identification, adulteration, contamination
atric research in herbals should be stimulated, encour-
with pesticides).
aged and rewarded in Europe. Research is very costly
and it is difficult to recoup investment but clinical trials
She described some current challenges in the TCM field
may not always be needed. Registries, real-world data
such as the availability of samples which are required for
or extrapolation may provide opportunities. To improve
monograph elaboration. These include commercial
the functioning of the system and the sustainability of
samples, authentic reference samples (to confirm that
the herbal medicinal products sector, the following are
commercial samples are both genuine and of an ac-
needed by the industry:
ceptable quality) and reference samples of substitute/
adulterant herbal drugs (for exclusion tests) are re-
Respect of community monographs. A survey con-
ducted by AESGP in 2015 found that more than half
of granted marketing authorisations/registration
Although processing may reduce toxicity and improve
(based on monograph) deviate from the monograph
the stability of TCM drugs, does it lead to an enhance-
for various reasons. The acceptance and relevance of
ment of activity? There are no uniform processing
EU Monographs is still very heterogeneous across
methods. Regional differences exist in China, for exam-
Member States. Generally there is a higher ac-
ceptance of THMPs monographs compared to well
established use (WEU) monographs. The main areas
Finally, the choice of markers for assays may not always
of deviation are the indications, age limits, and pre-
be indicative of quality, stability or activity. A pilot phase
clinical safety data.
using semi-quantitative HPTLC has started. This allows

Conference report

Assessment time in line with legislation. Currently This will ensure that the herbal medicinal products sec-
review timelines for THMPs are still extremely long, tor can remain competitive and safeguard innovation in
taking up to 3 years (based on an AESGP internal herbal medicines.

Fees proportionate to work going into the evalua-

tion. Fees should distinguish between Marketing au-
thorisations with or without a monograph as the pre-
clinical/clinical assessment would already be done by
the HMPC.

Resources and expertise on herbal medicines needed

within national agencies.

Simplified maintenance of herbal medicines taking

into account their known safety profile (simplified
variations). Currently any manufacturing change for a
herbal is considered a major variation. AESGP recent-
ly presented a proposal to the Regulatory Optimisa-
tion Group (ROG), a HMA subgroup focused on reg- Christelle Anquez-Traxler
ulatory/business optimisation, on the simplification
of the variation classification for herbal medicines.

Invitation to the Next AESGP Meetings

At the end of the conference, AESGP Director General, Dr Hubertus Cranz, invited participants to attend the next
AESGP meetings in Lisbon on the 26th-27th of February 2018, with the Heads of EU Medicines Agencies, and the 54 th
AESGP Annual Meeting in Amsterdam on the 5th -7th of June 2018.