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OVERVIEW OF
EUROPEAN MEDICAL
DEVICE REGULATIONS

WHITEPAPER October 2017

OVERVIEW OF EUROPEAN MEDICAL DEVICE REGULATIONS | October 2017

Table of Contents

Introduction 3

Changes to the Existing

Medical Device Directives 4

Timeframe for the Medical

Device Regulations Application 8

Conclusion 8

References 9

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OVERVIEW OF EUROPEAN MEDICAL DEVICE REGULATIONS | October 2017

Introduction
The Medical Device industry in Europe is going to witness a phenomenal
change in terms of regulation. This change has emerged as a result of
years of research by different institutional bodies to align the framework
at par with the one existing in the United States. A comparison of the
United States and European medical device market reveals that the
former has grown at a rate of 6.6% to reach above $155 billion in the year
2017, as against the European Medical Device market which is growing
at 2.6%. The Medical Device directives in Europe are very old and not
structured as per the current market needs, which are directly related
to the safety of the consumers who are going to use the device. A lack
of communication between different member states, lack of common
platform to register the adverse events, and lack of ability to track the
progress of different audits done at various levels, has put a break on the
progress of the industry. In addition, legislative bodies are not confident
about the quality of the marketed products.

All the above mentioned factors led to a decision for deep brainstorming
to revise the existing regulations in Europe for medical device and active
implantable medical devices. As a result, devices could be uniformly
regulated across the boundaries of different member states, and all the
member states could be timely informed of the changes and information
associated with a specific device placed in a lawful manner in the market.

With the introduction of the new Medical Device Regulations in Europe,

the way of governing numerous medical devices will change with the
alteration of their classification, the clinical data requirement, and vigilance
expectation. An additional requirement for multiple data and compliance
system can put financial burden over the manufacturers. This could lead
to a decision of killing certain products or getting merged with a bigger
firm who can afford to make added investment.

European Regulatory Structure, Medical Device Regulation Development,

and Triggers for Change

As per Article 13 of the Treaty of European Union (TEU) there are seven
institutions in Europe that govern the regulatory framework. Apart from
that, there are other institutions that are not formed under the treaty.
Out of the seven institutions, the European Parliament and Council for
European Union have legislative power. The European Council acts as
a body to shape political direction and priorities whereas the European
Commission acts as an executive responsible for proposing legislation,
implementing decisions, upholding the EU treaties, and managing the
day-to-day business of the EU.

The new Medical Device Regulations involve European Council, Council

for European Union, European Parliament, and European Commission.
The first idea of a new regulation came in the year 2008. The first draft
was published in the year 2012, and it finally enforced on 26 May 2017.
Fig.1: Journey of European Medical Device Regulations Development

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OVERVIEW OF EUROPEAN MEDICAL DEVICE REGULATIONS | October 2017

8 May to 2 July 2008 Subsequent meetings
 1st public  Consultation
2009, 2010 and 2011
29 Jun to 15 Sep 2010
Discussion  31 Mar and 1 Apr 2011
for Proposal:  2nd Public Consultation
Commission   MDEG:‐ Impact Assessment
Meetings
1st Draft Publishing 22 Mar & 6 June 2011 
08 Feb 2013
26 Sep 2012  Conference on Medical Device 
 Opinion of the European Data  Innovation
 Published as COM(2012) 0542 Protection Supervisor
 EU Council conclusion to adapt new 
 Appointment of a rapporteur by EU  legislation
Parliament to collect inputs 14 Feb 2013
Rapporteur  27 Apr & 28 Sep 2011
Report  Opinion of the European Economic 
and Social Committee  HMA/CAMD:‐ Legal Framework

6 & 13 Feb 2012
25 Sep 2013
 Discussion on issues related to
EU Parliament   1000 amendments collected. Draft 
Review Discussed with ENVI  Legislative proposals by MDEG

22 Oct 2013 14 Jun 2012
09 Oct 2013
 Start of the review  PIP breast implant scandal  lead to 
 Publishing of updated Report   Resolution by EU
 Publishing of results of plenary voting  Position of 
and discussion the European   Parliament to develop new 
Parliament framework
02 Apr 2014
 1st Reading  Trilogue negotiation: European 
Parliament, Commission and Council

5 Apr 2017 07 Mar 2017
 Council of EU: Stick with council   Adoption of position of Council
position of 1st reading
 Parliament 2 nd reading : Approve  05 May 2017 26 May 2017
without amendment
 Published in OJ  Enforced
 Sign of Proposal

Fig.1: Journey of European Medical Device Regulations Development

MDEG: Medical Devices Expert Group, CAMD: Competent Authorities for Medical Devices,
HMA: Heads of Medicines Agencies, ENVI: Committee on the Environment, Public Health
and Food Safety, OJ: Official European Journal, COM: Commission, EU: European Union)

The European Parliament found that existing directives were outdated

and understood and interpreted by the various stakeholders in different
ways. The problems with existing directives for medical devices continue
to be highlighted due to the incidents that happened with specific
instances like the breast implants and metal hips. All these factors
influenced the European Medical Device market to enact a regulatory
system that consistently ensures high level of safety, enables fair trade
of different devices across European boundaries, and promotes scientific
and technological progress.

Changes to the Existing Medical Device Directives

The new European Medical Device Regulations has 10 Chapters, 123
Articles, 22 Rules and 27 Annexures. There are 32 implementing acts
(08 are compulsory) and 11 delegating acts. At a high level, some of the
changes that are deemed to be introduced by the new Medical Device
Regulations include:
• The high risk devices that were previously regulated, with no difference
from any other form of device, would have strict control and see an
involvement of experts from regulators.
• The controls over notified bodies involved in the majority review will
be reinforced.
• Some of the cosmetic/aesthetic products that were previously left
out from the definition of medical device are now included

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OVERVIEW OF EUROPEAN MEDICAL DEVICE REGULATIONS | October 2017

• Transparency for better control of devices will be ensured through

the use of European Database, which would be used by all the
manufacturers, notified bodies, and the regulators.
• The traceability of the medical devices will be ensured through a
mandate for the implementation of Unique Device Identifiers.
• Coordinated approach for union wide clinical investigations.
• Reinforcement of clinical evidence and post market surveillance
related rules.
• Provision for defining single use devices that can be reprocessed.

Major changes brought up in different sections of the Medical Device

Regulation are:

Chapter Changes

CHAPTER I • More definitions to address the increased scope

• Products intended for cleaning, disinfection, and
Scope and sterilization defined as medical devices
Definitions • Devices that do not meet the definition of
medical devices, but have “medical character” are
listed in Annex XV
• Definition of accessory broadened. Devices that
“assist” and not just “enable” are considered as
accessories
• Definition of Label and Common Specification
introduced; definitions related to clinical
evaluation and vigilance adopted from MEDDEVs
• “Standalone software” mentioned as ‘software
that are devices in themselves’ or ‘independent of
any other device’

CHAPTER II Placing • Annex I is changed to “General Safety and

Devices on the Performance Requirements”. New requirements
Market are included.
• Reduction of risk ‘as far as possible’ is explained
as reducing ‘without adversely affecting the risk
benefit ratio’ and manufacturers are required to
establish, implement, document, and maintain a
risk management system.
• New requirements include but are not limited
to, devices incorporating a medicinal product;
devices composed of substances or combination
of substances intended to be absorbed or
locally dispersed in the human body; devices
incorporating materials of biological origin;
construction of devices and interaction with
their environment; software in devices and
software that are devices in themselves; particular
requirements for active implantable devices and
risks concerning medical devices for lay persons.
Devices that contain more than 0.1% in weight of
a carcinogenic, mutagenic or toxic substance/
substances having endocrine disrupting
properties, need to have a justification for their
presence. Unauthorized access to active devices
must be avoided, this includes software.

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OVERVIEW OF EUROPEAN MEDICAL DEVICE REGULATIONS | October 2017

Chapter Changes

CHAPTER III • Introduction of database “EUDAMED” to share

Identification and device information and interact with other
Traceability existing databases to provide information on the
device.
• Introduction of Unique Device Identification (UDI)
number to facilitate traceability of devices.

CHAPTER IV • More stringent norms for NBs to oversee and

Notified Bodies inspect manufacturers
• Appointment of expert panel to review the
clinical evaluation assessment performed by NB
on Class III implantable devices and Class II b
devices intended to administer medicinal product

Chapter V • Annex VIII proposed in MDR has 22 rules

Classification • Non-invasive devices in contact with cells, tissues
& Conformity or organs in vitro is placed in Class III
Assessment • Rule 4 is also applicable to devices that come into
contact with injured mucous membrane
• Reusable surgical instruments are placed in
Class I, however, Notified Body involvement is
introduced.
• Rule 8 places Breast Implants, Surgical Meshes,
total or partial joint replacements, and spinal disc
replacement implants in Class III
• For software, “Rule 11” is introduced
• Devices manufactured using non-viable tissue or
cells of human or animal origin or their derivatives
are placed in Class III per Rule 18
• Nano-materials are classified under Rule 19

Chapter V • Rule 21 places devices composed of substances

Classification absorbed or dispersed in different classes, based
& Conformity on their level of internal exposure.
• Rule 22 places active therapeutic devices with an
Assessment
integrated diagnostic function, which significantly
determinates the patient management by the
device in Class III (e.g. closed loop systems or
automated external defibrillators).
• Annex II – Technical Documentation is introduced
to provide information on the content to be
produced in Technical File.
• Unannounced inspections of manufacturer and
manufacturer’s suppliers or subcontractors will be
performed by NB at least once every five years.

NB is mandated to test samples from the production

or manufacturing process.

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OVERVIEW OF EUROPEAN MEDICAL DEVICE REGULATIONS | October 2017

Chapter Changes

CHAPTER VI • Clinical evaluation and clinical investigation is

more stringent.
Clinical Evaluation • MEDDEV 2.7/1 and parts of ISO 14155 (clinical
and Clinical investigations) is included into MDR.
Investigation • More emphasis on informed consent and the
protection of incapacitated subjects

Clinical Data to be entered in EUDAMED (European

Database for Medical Device)

CHAPTER VII & • For implantable and Class III devices, periodic
IX Post Market reports on safety, sales and population using the
Surveillance & Data device should be entered into EUDAMED, which
will be reviewed by NB, which in turn, will be
Protection reviewed by competent authorities
• Serious incident or Field Safety Corrective Action
should be recorded in EUDAMED within 15 days
• Death or unanticipated serious health
deterioration should be reported within 10 days
and serious public threat to be reported within 2
days.
• Though it is an open database, confidentiality
of device and patient information is to be
maintained

CHAPTER VIII & X • Independent expert panels to assist MDCG is

Final Provisions introduced
• MDCG to play a significant role in standard
development, CS, and guideline development.
• Regulation will apply three years after its formal
publication in the Official Journal of the European
Union (OJEU).
• Certificates issued under the current system may
remain valid until they expire. However, Notified
Bodies may issue certificates to the Medical
Device Directive (MDD) or Active Implantable
Medical Device Directive (AIMDD) until the
date of entry into force, that are valid for five
years to allow for a smoother transition period,
though at the latest, become void four years after
application of the MDR.
• Devices legally placed on the market compliant
to the MDD or AIMDD and prior to the date of
application can be sold until five years after that
date.
• NBs that have been accredited before the date of
application can start issuing certificates under the
Regulation.

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OVERVIEW OF EUROPEAN MEDICAL DEVICE REGULATIONS | October 2017

Timeframe for the Medical Device Regulations

Application
The medical device industry has lived for years with the old medical
device directives. There is a lot of background work and preparedness
to be done before the industry and competent authorities become ready
for the change. Considering all these aspects, the European Commission
has set a three years transition phase from the date of enforcement to
application.
Plan to implement 
Article 35 to 50 Article 101 Article 103 Article 102 functional spec
Notified Body CA MDCG EU Cooperation EUDAMED
MDR ‐ OJ Article 78

05‐May 26‐Nov
Coordinated 
26‐May Clinical 
UDI Article 120(12) Investigation
26‐May Article 29(4) & 56(5)
18 months 26‐May
EUDAMED ‐ OJ1 EUDAMED usage
25‐May

Y0 Y1 Y2 Y3 Y4 Y5 Y6 Y7 Y8 Y9 Y10 Y11
2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028

26‐May 27‐May 26‐May 27‐May 26‐May 27‐May

26‐May 26‐May
Enforcement Application 1Articles related to obligations and 

EC verification requirements of EUDAMED will be applicable 
All other type of  certificate  Either on date of MDR application (26 May 
Validity of CE Marking 
2020)
as per MDD2
Maximum 5 years  If not then,
 6 months  after 25 mar 2020 
Implantable  or  6month after publish of notice in OJ
UDI on  all higher  Class IIa & IIb
2Additional compliance requirements for PMS, 
levels of packaging3 Class I
registration of economic operators as per MDR 
As per Article 27(4)
3Reusable devices: UDI carrier on the device 

itself. UDI Implementation after 2 years of 
mentioned dates.

1
Fig 2: Timeline for application of European Medical Device Regulations

The defined transition considered the applicability of the certificates

issued by the notified bodies as well as gave due consideration for the
validity of the market authorization issued after the date of enforcement.
A differential date of application of the different articles allows smooth
transition and provision of making a market authorization request even
before the final application of the regulation.

Conclusion
The latest change in the European Medical Device Regulations is going
to affect the operation of different entities ranging from economic
operators, manufacturers, service providers, competent authorities, and
European Institutions. The changes are seen with a positive intent by
the Medical Device industry and it is believed that the changes will open
new doors for innovation and safer development of medical devices. At
HCL Technologies, a wide pool of regulatory consultants are involved in
providing expert services to industries to cater to the change within the
required timeframe.

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OVERVIEW OF EUROPEAN MEDICAL DEVICE REGULATIONS | October 2017

References
http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=consil:ST_9364_2016_REV_3

http://www.raps.org/Regulatory-Focus/News/2017/02/23/26946/Final-Versions-of-EU-
MDR-IVD-Released-Voting-Begins-Next-Month/

http://www.gs1.dk/media/1793/salvatorescalzo_beijing2016.pdf

http://info.moravia.com/blog-life-sciences/how-will-the-new-eu-medical-device-
regulations-affect-translation-requirements

https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en

Author Info

Dr. Nishant Paliwal is a Ph.D. in Pharmaceutical

Sciences and he is a certified GLP/GCP auditor
working as a Consultant for Quality/Regulatory
Services in the Medical Domain. Nishant has over 13+
years of experience and deals closely in regulatory
affairs and quality matters with USFDA, ANVISA,
CDSCO and different European regulatory bodies.

Co -Author Info
Mohammed Adil is a post graduate in Drug Design
and Biomedical Science. He is a certified Quality
Management System Lead Auditor and Laboratory
Quality Management System Internal Auditor.
He has been consulting in Quality / Regulatory
Compliance for 7+ years, assuming responsibilities
as a quality/ regulatory engineer, technical lead for
system verification and validation, and computer
system owner.

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HCL Technologies (HCL) is a leading global IT services company that
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