Introduction to CE

Before we look at CE marking in Europe, bear in mind the following facts: The European Union boasts
28 member states, a population of more than 500 million and 24 languages. Furthermore, as it relates
to medical devices, Norway, Lichtenstein, Iceland, and Switzerland are additional countries that have
transposed European laws into their national legislation. Even Turkey, an EU candidate member state,
has transposed the Medical Devices Directive MDD 93/42/EEC. Together, these countries total more
than 600 million people and are tremendous market opportunities for medical device manufacturers.

CE Certification?
The three medical device directives: Medical Devices Directive (MDD) 93/42/EEC; Active Implantable
Medical Devices Directive (AIMDD) 90/385/ EEC; and In Vitro Diagnostic Directives (IVDD) 98/79/EC
define essential requirements and (for medical devices) characteristics such as risk assessment and
patient safety.

As of May 2016, Europe had not yet released the long awaited version of the
Medical Device Regulation (MDR). The MDR will replace the MDD. This white
paper does not cover those changes. Rather we focus on the process as it
exists today. If you want to take a deep dive into the changes coming in the
next MDR, download our white paper on the topic.

In addition, chemical, physical, and biological properties are delineated, but the directives do
not necessarily prescribe specific technical requirements to permit flexibility, innovation and
development of devices. It was envisioned that European harmonized standards published in the
Official Journal of European Communities would facilitate compliance with Essential Requirements
of the directives, as compliance with such standards presumes compliance with relevant
Essential Requirements.

CE as a Quality Mark?
It is a common misconception that CE Marking is a distinction of quality or a mark of consumer
assurance, and that a CE certificate guarantees this. In reality, CE Marking is an attestation by
the manufacturer of compliance with the appropriate directives’ requirements. Devices that meet
applicable Essential Requirements and have gone through the appropriate conformity assessment routes will
be granted CE “certification.”

One should note that while a product may be subject to multiple directives, the MDD is a specific
directive and takes precedence over the other directives. For example, medical devices subject
to both the MDD 93/42/EEC and the Electromagnetic Compatibility Directive EMC 2004/108/EC
possess CE marking to the MDD but still are subject to the relevant
provisions of the Electromagnetic Compatibility Directive.

Medical devices that also are machinery as defined by the

Machinery Directive 2006/42/EC are CE marked to the MDD;
however, where relevant hazard exists, they also must meet the
essential health and safety requirements relating to the design and
construction of machinery (Annex I, Machinery Directive) when the
requirements are more specific than essential requirements (Annex
I in the MDD).

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 Parties Involved in CE Marking

The Manufacturer
The manufacturer is the person responsible for designing and manufacturing a product covered
by a Directive. Regardless of whether a manufacturer outsources design or manufacturing, they
are ultimately responsible for the product and compliance with the respective national laws.
In accordance with European legislation, a person acting as the manufacturer of the product,
even if he or she is not the producer, is considered a manufacturer in the eyes of the law. This
also applies to the “private labeler” who does not manufacture the product, but places it
on the market under his or her brand name. The “private labeler”, therefore, as a “de facto”
manufacturer, is ultimately responsible for compliance with all requirements, including post-
market surveillance.

The Authorized Representative

An Authorized Representative (AR) is an entity appointed by the manufacturer and delegated to
act on their behalf to carry out certain tasks required by the medical device directives. The AR
must be established inside the European Union and be available to Member State Authorities.
The manufacturer, however, remains ultimately responsible for the actions carried out by the AR.
The appointment of the AR is required if the manufacturer is not located in the EEA.

The directives require that the AR be listed on the

device label or packaging, in the Instructions for Use

EC REP
and on the Declaration of Conformity. In addition, the
AR keeps the Technical File available for review by
Competent Authorities, and plays an essential role in
the post-market surveillance and vigilance system.

The Importer and Distributor

An importer is loosely defined as an entity legally established within the European Union who
places a product from a country outside the EEA on the European market. The Distributor can
be the importer, but is NOT considered as such if the goods they distribute are procured from
within Europe. The role of a distributor who is NOT the importer is not clearly defined in the law
with regard to post-market surveillance and vigilance, despite the fact that distributors are an
important entity in the distribution chain.

The Competent Authorities

Competent Authorities are usually the national Ministries of Health. They are responsible
for monitoring medical products on the market and taking appropriate steps to ensure that
dangerous products don’t enter (or are removed from) the marketplace. As such, the Competent
Authority may require access to the manufacturer’s Declaration of Conformity and Technical File/
Dossier. The manufacturer, his Authorized Representative, or importer must be able to provide
these documents upon request. If the product is found to be non-compliant, corrective action
will depend on, and be appropriate to, the level of non-compliance.

It should be noted that the Competent Authority will hold accountable the person (in most cases,
the manufacturer) who was responsible for affixing the CE marking to a non-compliant product.
Others who are responsible for the non-compliance of the product will be held accountable
as well.

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 Parties Involved in CE Marking

Customs Officials
The creation of the European internal market has resulted in the disappearance of borders
between European Union Member States, thus making enforcement a lot more effective, and
giving an increased role for border Customs agents in market surveillance. Customs officials have
focused on getting up to speed with medical device legislation and are becoming more efficient
with product inspections. There have been increased communications and requests coming from
Customs officials regarding regulatory compliance, and non-European manufacturers are more
exposed to Customs inspections than their European counterparts.

The Notified Bodies

Notified Bodies are independent testing houses, laboratories, or product certifiers authorized
by the EU Member States to perform the Conformity Assessment tasks specified in the
directives, such as quality system audits and device compliance testing. A Notified Body is
appointed by a Member State and must have the necessary qualifications to meet the testing
and/or certification requirements set forth in a directive. A Notified Body not only needs to
be technically competent and capable of carrying out the specified conformity assessment
procedures, it must also demonstrate independence, impartiality and integrity.

Devices that qualify for CE self-certification by the manufacturer do not require the intervention
of a Notified Body. Medium and higher risk devices, however, do require the intervention of a
Notified Body, which will be responsible for auditing the manufacturer’s quality system. The
Notified Body will also determine whether or not the product conforms to the requirements
of the applicable directive. The Notified Body will audit the manufacturer’s quality assurance
system or carry out testing and some form of production audit or sample examination.

The End User

End users play an important role in the vigilance chain because they report events and/or
findings to Competent Authorities, manufacturers, Authorized Representatives and distributors.
Certain European Member states have regulated reporting schemes in which, for example,
medical professionals or hospitals are required to report incidents to Competent Authorities.
As more Competent Authorities put increased emphasis on monitoring product performance
in the marketplace and making sure that manufacturers are implementing proper surveillance
procedures, post-market surveillance will become an important issue for manufacturers,
Authorized Representatives, importers, distributors and end users.

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 Guidance Documents

Guidance documents warrant careful consideration from manufacturers pursuing CE Marking.

These documents provide the strongest written consensus of how directives and their
components are interpreted by European regulators. Many of the entities involved in the
European medical device industry also have designated groups that develop and issue guidances
as well. A good way to consider guidance is as a set of instructions or directions that further
explain medical device legislation.

Major European Guidance Documents Include:

• EU Commission Guidance: The European Commission was granted the “right of initiative”
in the legislative process to propose legislation ratified by the European Parliament and
Council. In this capacity, the EU Commission also publishes guidance to provide explanations
to the directives. As an example, the EU Commission published an interpretive document
explaining the relationship between the revised directives 90/385/EEC and 93/42/EEC and
the Machinery Directive 2006/42/EC.
• MEDDEV Guidance Documents: The EU Commission established the Medical Device Expert
Group (MDEG). It is composed of delegates from Member State Competent Authorities and
other well-known EU organizations including EUCOMED, EDMA, CEN, CENELEC, NB-MED and
EAAR. The MDEG is best known for publishing MEDDEV Guidance Documents. These items
reflect the consensus position of its members on such issues as the demarcation between the
MDD and AIMDD Directives, definition of accessories, classification of devices, translation
procedures and much more. MDEG opinions are not legally binding, but are considered the
“highest” of guidelines in the industry.
• NB-MED Guidance Documents: The EU Commission and individual countries formed the
Notified Body Operations Group (NBOG) in 2000 to address concerns about the inconsistent
performance of notified bodies in medical devices and the competent authorities responsible
for them. Essentially, the NBOG identifies and communicates “best practices” for notified
bodies and reports on their progress at the semi-annual meeting of the Competent
Authorities and the MDEG. One member of the NBOG usually produces a written guidance,
which is then circulated to the other members for comment.

Regulatory Documentation & Notified Body Involvement

The regulatory documents compiled to demonstrate that the medical devices are in compliance
with the requirements of the MDD are called technical files and design dossiers. Typically,
technical files are compiled for Class I, Class IIa and Class IIb medical devices; design dossiers are
drafted for Class III medical devices.

Manufacturers self-certify Class I non-measuring and non-sterile devices, which implies that
Notified Body involvement is not required. Thus, no CE certificate is issued. Class I sterile and
measuring, Class IIa and Class IIb devices require Notified Body interaction, as do Class III devices.
Notified Body engagement is designated by a CE certificate with a four-digit notified body
number (individual identifier) on it. It is obvious from Directive 2007/47/EC that the Notified
Body will be required to more vigorously review technical files for Class IIa and Class IIb
medical devices.

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 The Declaration of Conformity

The DOC is a one-page document used to “declare” your “conformity” to the Essential
Requirements of the European Medical Devices Directive (or other appropriate directive). Annex
7 of the Directive explains the need for an EC Declaration of Conformity.

All medical device manufacturers–those that self-declare as well as those that require Notified
Body intervention–must prepare a DOC, a legally binding document that should be signed by a
senior company executive. The DOC serves as a sworn statement in which you declare publicly
that you have met all regulatory obligations necessary to market your device in Europe.
Some Notified Bodies require manufacturers to have a completed and signed DOC as part of
their Technical File for their device registration process, which in most cases occurs before or
during an on-site registration audit. As the DOC is a legally binding document, you should only
sign it once you have met all Essential Requirements, including a successful on-site inspection by
a Notified Body.

If you must provide your Notified Body with a signed copy of your DOC before you have met all
necessary Essential Requirements, clearly identify that copy with a stamp that says “DRAFT.”

People often confuse the CE certificate with the DOC. It’s important to note that you
should first meet all regulatory compliance requirements and obtain CE certification
before preparing your DOC. It is best practice to identify the CE certificate number
on your DOC, and you will also need to list your Notified Body along with its four-digit
identification number, if applicable.

DOC Elements
The DOC must be printed on your company letterhead and should include the following pieces
of information:
• Device trade name and model number
• Device classification (Class and Rule)
• Your company name and address
• Name of quality management representative
• Notified Body name and ID number (if applicable)
• CE certificate number (if applicable)
• Date CE Marking was first applied
• Authorized Representative contact information
• Route to compliance (example: Annex 2, 5, 7)
• Standards applied (optional)
• Name, title, and signature of company officer

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 The Declaration of Conformity

Medical device harmonized standards developed specifically to deal with Essential Requirements
of the directives provide the presumption of conformity. In the absence of these standards, a
manufacturer is entitled to comply by using any appropriate specifications that can demonstrate
conformity with the Essential Requirements.

Your DOC must be written in one of the European Union’s official languages—which luckily
includes English.

Many questions come up regarding preparation of a DOC. Here are some of the most
common ones:

Declaration of Conformity Q&A

Q. Does the DOC need to be included in shipments?
A. Technically, you are not required to send your DOC along with your shipments, but it is
recommended that you do. Providing a DOC is one more way you can demonstrate to
customs officials and Competent Authorities that your products fully comply with the
Medical Devices Directive.
Q. Should a DOC be updated every year?
A. It is not required that you update your DOC once per year, but the DOC (along with the
technical file/design dossier) should be reviewed periodically and updated as necessary.
It is also required to be updated as new devices are added to the device family covered by
that particular DOC.
Q. How long must a DOC be maintained in a Technical File?
A. You are required to maintain a copy of your Technical File that includes your DOC for five
years, and in the case of implantable devices at least 15 years after the date your device
was last manufactured.
Q. Does an officer have to physically sign every DOC that rides along with shipments
to Europe?
A. No, a digital signature is fine, but we recommend that you print every copy of your DOC
on original letterhead to maintain a sense of protection and authenticity.
Q. Who should receive copies of my DOC?
A. Give copies of your DOC to your distributor(s) and Authorized Representative. In the event
of a problem with customs officials or Competent Authorities, having DOC information on
file will help these entities resolve issues more efficiently.

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 To Learn More...

Need help with Europe? Learn more about Europe

Emergo helps medical device companies with If you enjoyed this white paper, we know you will like
regulatory compliance and market access in Europe our in-depth video explaining medical device approval
and other markets worldwide. and compliance in Europe. We discuss the CE Marking
framework, device classification, QMS compliance,
• European CE Marking for medical devices and IVDs
Technical File preparation,
• ISO 13485:2003 and ISO 13485:2016 and key players in the CE
implementation Marking process.
• Technical File preparation and submission Watch the video now
To learn more, visit: See all Europe content
www.emergogroup.com/services/europe

About the Author

Elizabeth Pugh: Elizabeth Pugh is a Regulatory Affairs Consultant at
Emergo. She has over 15 years of experience with regulatory affairs in
the medical devices industry, and previously held positions at Stryker,
FoxHollow Technologies, and DJO Surgical. Her areas of expertise
include CE Marking compliance, post-market surveillance, and global
vigilance reporting.

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