LNE G-MED CE Guide

CE MARKING OF MEDICAL DEVICES
CE MARKING
OF MEDICAL DEVICES
Edition 2012
Do not distribute or reproduce without permission
Copyright 2012. LNE/G-MED North America, Inc. All rights reserved - www.LNE-america.com
Table of Contents
1. Introduction to the guide ................................................ 3
5. Demonstrating the Conformity to the European

Regulatory Scheme: Some Key Principles ......................... 18
2. The Regulatory Scheme for Medical Devices in Europe 4
5.1 Demonstrating Product Conformity
2.1 Context .................................................................................... 4
to the Essential Requirements .................................................... 18
2.1.1 Particular Case of the Common Technical Specifications 5
5.1.1 Essential Requirements ....................................................... 18
2.2 To which products do the Directives apply? ......................... 5
5.1.2 Risk Management ................................................................ 18
2.3 What can a manufacturer do when the regulatory texts dont
5.1.4 European Harmonized Standards ....................................... 19
answer his or her questions Where to find interpretations?
5.1.5 Common Technical Specifications ...................................... 19
....................................................................................................... 7
5.2 Demonstrating Conformity of the Quality System ................ 19
2.4 Who is responsible for placing medical devices

on the market?.............................................................................. 7
6. Maintaining CE Marking ................................................. 20
2.4.1 Manufacturer ........................................................................ 8
6.1 Full quality assurance system ............................................... 20
2.4.2 Other Parties ........................................................................ 8
2.5 Role of Notified Bodies .......................................................... 9
6.1.1 If the examination of the design

of the product has been done ....................................................... 20
6.1.2 General cases....................................................................... 21
3. What should a manufacturer do before contacting

LNE/G-MED or another Notified Body? .............................. 10
3.1 Who is the Manufacturer of the Product? ......................... 10
3.2 Characterizing the Product .................................................... 11
3.3 Determining the Applicable Directives ................................. 11
3.4 What is the Class of the Medical Device? ............................ 11
6.2. Production quality assurance ............................................... 21

6.3. Product quality assurance .................................................... 21
6.4. EC type-examination ............................................................. 21
6.5 EC verification......................................................................... 22
6.6 EC declaration of conformity ................................................. 22
6.7. Verification of manufactured products................................. 22
3.4.1 Case of Directive 93/42/EEC Medical Devices .............. 11

3.4.2 Case of Directive 98/79/CEE In Vitro Diagnostic Devices 12
7. Conclusion ........................................................................ 23
4. Deciphering the Role of the Notified Body .................... 15
Annexes ................................................................................ 24
4.1 Design: Examination of the Medical Devices Design
Annex A: Conformity Assessment Routes for Medical Devices
Conformity with the Essential Requirements.............................. 15
under Directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD)

....................................................................................................... 24
4.1.1 Design Examination ............................................................. 15

4.1.2 EC Type Examination ............................................................ 16
4.2 Evaluating the Manufacturers

Quality Management System ....................................................... 16
4.2.1 Complete Quality Assurance System .................................. 16
Class I Medical Devices ................................................................. 24

Class IIa Medical Devices .............................................................. 25
Class IIb Medical Devices .............................................................. 26
Class III Medical Devices and Active Implantable Medical Devices
(AIMD) ............................................................................................. 27
4.2.2 Production Quality Assurance ............................................. 16
Annex B: Conformity Assessment Routes for In Vitro Diagnostic
4.2.3 Product Quality Assurance .................................................. 16
Medical Devices under Directive 98/79/EEC (IVDD) ................. 28
4.3 Evaluating the Conformity of Each Lot of the Product ......... 17
Devices Referred to in Annex II, List A .......................................... 28
4.3.1 EC Verification....................................................................... 17
Devices Referred to in Annex II, List B .......................................... 29
4.4 Verification of Manufactured Products
Self-Testing Devices (Except those in Annex II) ............................ 29
(The Only Assessment Procedure Under the IVDD) .................... 17
General IVDs ................................................................................... 29
4.5 Case of Devices Incorporating a Medicinal Product ............ 17
1. Introduction to the guide

The National Metrology and Testing Laboratory (LNE) is a widely-recognized European Notified Body with lots
of experience in the European regulations. As a Notified Body, LNE evaluates and certifies a wide range of
business and consumer products to be sold in Europe. LNE wanted to focus its expertise on the certification
of medical devices within its subsidiary, LNE/G-MED. This subsidiary focuses on the medical device market
to help manufacturers market their devices in Europe.
This guide is for medical device and in vitro medical device manufacturers who may call on LNE/G-MED to
receive the necessary certificates for CE Marking to put their products on the European market. This guide
is no substitute for the regulations or the official guidance documents.
To comply with the provisions of the Directives, manufacturers must develop a strategy. The Directives
governing medical devices are not guidelines, but rather laws that must be followed. While the Directives
may seem straightforward, the reality is that implementing the requirements is usually much more difficult
than initially perceived. As a result, it is important to develop a strategy for implementing the Directives
requirements. With this Guide, LNE/G-MED will explain the requirements in the Directives, giving the
manufacturer the ability to create a strategy unique to their device that will help usher their device into
Europe.
Even though complying with the directives could be difficult, the directives also offer the manufacturer
choices. Manufacturers face an optimization problem as they must reflect the interests and realities of their
business. This guide, we hope, will help to determine the solution that is best suited to the manufacturer
and make the best possible route for the manufacturer, along with LNE/G-MED to put its products on the
European market. To do so, this guide aggregates the main content of the guidance documents for each
issue addressed and discusses the links with the most relevant European standards.
LNE/G-MED is available to manufacturers to discuss any questions raised by their specific situation. Through
Regulatory and Technical Assistance, LNE/G-MED helps to formulate a strategy that is best suited to the
manufacturer.
2. The Regulatory Scheme for Medical Devices in Europe

2.1 Context
By the Single Act in December 1985, the Member States of the European Economic Community (EEC)
created an area with no internal borders to allow the free movement of people, goods, and services. Practically,
this meant the removal of technical barriers to trade. These had their origin in the national technical rules
and regulations which showed specific differences from one country to another. For medical devices these
internal borders were especially onerous because each country maintained its own safety laws. They could
not be removed by substituting these national regulations harmonized Community rules guaranteeing a high
level of protection for the user and the consumer safety and health.
However, the New Approach harmonized many technical barriers, allowing for freer medical device trade
within the EEC.
Some major objectives and principles of the New Approach are:
Freedom of movement for CE-marked devices throughout the European Economic Area;1
CE marking is mandatory for marketing medical devices in Europe, except for devices intended for
clinical investigations, custom-made devices2, or IVDs for performance evaluation;
CE marked devices conform to all the Essential Requirements as defined in the relevant
directives.
The procedures for determining compliance with the Essential Requirements. These procedures
include when a manufacturer would use a third party, or a notified body. Notified bodies issue
certificates that are valid for marketing a device across the European Economic Area, regardless of
which Member State the notified body comes from.
Implementing the Directives requires transposing them into national law after they are published in
the Official Journal of the European Community. The EU Directives are addressed to the Member
States, so the Member States incorporate the Directives provisions into their laws and regulations
without making changes to the provisions.
The Directives cover the definitions of the various types of medical devices, who is responsible for marketing
medical devices, and coordinating with Notified Bodies and other actors in the regulatory process. In this
framework, the three principal directives adopted that relate to medical devices are:
Active Implantable Medical Device Directive (90/385/EEC of 20 June 1990), modifying directive
93/42/EEC, modified by directive 93/68/EEC, modified by regulation 1882/2003, modified by
directive 2007/47/EC;
Medical Device Directive (93/42/EEC of 14 June 1993), modified by Directive 2007/47/EC of 5
September 2007, modified by directive 2001/104/EC, modified by regulation 1882/2003, modified
by directive 2007/47/EC; and
In Vitro Medical Device Directive (98/79/EC of 27 October 1998), rectified by the corrigendum of
25.5.2000, modified by regulation 1882/2003 and regulation 596/2009.
Other directives that apply to more specific medical devices also apply. Their relations with the three principal
directives are defined in their text:
1
The European Economic Area (EEA) consists of the member states of the European Union, Norway, Iceland and Liechtenstein which are member states of the
European Free Trade Association (EFTA).
2
93/42/EEC
Medical Devices Incorporating a Human Blood Derivative or Human Plasma (2000/70/EC of 16

November 2000);
Breast Implants (2003/12/EC of 3 February 2003);
Medical Devices Using Substances of Animal Origin (2003/32/EC of 26 April 2003); and
Reclassification of Hip, Knee, and Shoulder Joint Replacements in the Framework of Directive
93/42/EEC Relating to Medical Devices (2005/50/EC of 11 August 2005).
2.1.1 Particular Case of the Common Technical Specifications
Directive 98/79/EC introduces, for its most critical devices those mentioned in its Annex II List A and List
B, if any the concept of common technical specifications (CTS). They establish criteria for evaluation and
re-evaluation of performance, batch release criteria, reference methods and reference materials. They
are prepared by experts from Member States authorities, formally adopted and published in the OJEU.
Manufacturers are generally required to comply with the CTS. If, for duly justified reasons, they do not
comply with those specifications, they must adopt solutions of an equivalent level.
These texts are available at:
http://ec.europa.eu/health/medical-devices/regulatory-framework/legislation/index_en.htm
http://ec.europa.eu/health/medical-devices/documents/index_en.htm
2.2 To which products do the Directives apply?

In all cases, it is fundamental that before a manufacture gets to the Essential Requirements, it must
determine and verify which regulation governs their products market entry. To figure out which devices are
covered by which Directives, a manufacturer can look at the first articles of the Directives, which contain
the definitions and exclusions.
The Medical Device Directive3 defines medical device as:
...any instrument, apparatus, appliance, software, material, or other article, whether used alone
or in combination, including the software intended by its manufacturer to be used specifically for
diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the
manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception,
and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its function by
such means.4
The In Vitro Diagnostic Medical Device Directive5 defines in vitro medical device as:
93/42/EEC
93/42/EEC Art. 1(2)(a).
98/79/EC
any medical device which is a reagent, regent product, calibrator, control material, kit,
instrument, apparatus, equipment, or system, whether used alone or in combination, intended
by the manufacturer to be used in vitro for the examination of specimens, including blood and
tissue donations, derived from the human body, solely or principally for the purpose of providing
information:
concerning a physiological or pathological state, or
concerning a congenital abnormality, or
to determine the safety and compatibility with potential recipients, or
to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. Specimen
receptacles are those devices, whether vacuum-type or not, specifically intended by their
manufacturers for the primary containment and preservation of specimens derived from the
human body for the purpose of in vitro diagnostic examination.
Products for general laboratory use are not in vitro diagnostic medical devices unless such
products, in view of their characteristics, are specifically intended by their manufacturer to be used
for in vitro diagnostic examination.6
Further details on the interpretations of these definitions are detailed in the following MEDDEV guides
(cf 2.3):
MEDDEV 2.1/1
MEDDEV 2.1/2
MEDDEV 2.14/1
MEDDEV 2.14/2
Other devices that are not considered medical devices are:
Medicinal products covered by Directive 2001/83/CE;
Cosmetic products covered by Directive 76/768/EEC;
Human blood and human blood products, human plasma or blood cells of human origin or to
devices which incorporate at the time of placing on the market such blood products, plasma, or
cells;
Human transplants, tissues, cells, or products incorporating or derived from human tissues or cells;
Animal origin transplants, tissues, or cells unless a device is manufactured using animal tissues
rendered non-viable or non-viable products derived from animal tissues.
For the record, based on 14 years of experience, the regulatory recast that began in 2012 confirmed the
extension of the medical device regulations of medical devices to certain products without direct medical
purpose. These are products for esthetic purposes whose use may represent health hazards: non-corrective
contact lenses, implants for augmentation, fixation or sculpting of body parts, skin fillers, liposuction devices,
and lasers.
Regarding the field of diagnostic medical devices in vitro, software has been confirmed as part of the scope
of the draft, together with, for example, products intended to screen for predisposition to a medical condition
or disease.7
98/79/EC Art. 1(2)(b).
Editors note: this data may change during the year 2012.
2.3 What can a manufacturer do when the regulatory texts dont answer his or her questions Where to find interpretations?
Despite the drafters best intentions, the reality of regulations and legislations is that sometimes they need to
be clarified to be understood and applied in a consistent manner. To help readers, the European Commission
develops guides and interpretive texts for the Directives to clarify some points. These guides are drafted by
experts from different Member States, although it should be noted that they arent legal texts as such. But
these guides provide significant help in interpreting, applying, and avoiding mistakes with the Directives.
These texts, the MEDDEV guides, are interpretive documents or consensus statements that do not have a
regulatory status. Therefore, the basis of a decision or action remains the Directives themselves and their
implementation into national law of the Member States. However, their use represents an important aid for
interpreting and applying the Directives and avoiding mistakes with very damaging consequences
These guides can be found on the European Commissions website,8 and others on NBOGs website.9
Finally, it is worth mentioning the important guide to the European Commission intended to explain the
concepts of the New Approach. This guide, the Blue Guide, covers the placing all CE marked products on
the European market and is not limited to medical devices.10
The experts from LNE/G-MED are able to help to analyze the contents of these different guides.
2.4 Who is responsible for placing medical devices on the market?

The directives define placing on the market as:
the first making available in return for payment or free of charge of a device other than a device
intended for clinical investigation, with a view to distribution and/or use on the Community market,
regardless of whether it is new or fully refurbished.
An interpretive document from the European Commission is available on this point at: http://ec.europa.eu/
health/medical-devices/files/guide-stds-directives/placing_on_the_market_en.pdf.
Putting into service is:
the stage at which a device has been made available to the final user as being ready for use on
the Community market for the first time for its intended purpose.
8
http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm.
http://ec.europa.eu/health/medical-devices/documents/consensus-statements/index_en.htm
http://ec.europa.eu/health/medical-devices/documents/interpretative-documents/index_en.htm
9
http://nbog.eu/index.html
10
http://ec.europa.eu/enterprise/policies/single-market-goods/files/blue-guide/guidepublic_en.pdf
2.4.1 Manufacturer
The manufacturer takes the responsibility for placing the medical device on the market. The Directives
define a manufacturer as:
The natural or legal person with responsibility for the design, manufacture, packaging and labelling
of a device before it is placed on the market under his own name, regardless of whether these
operations are carried out by that person himself or on his behalf by a third party.
The obligations of this directive to be met by manufacturers also apply to the natural or legal person
who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made
products and/or assigns to them their intended purpose as devices with a view to their being placed
on the market under his own name. This subparagraph does not apply to the person who, while not
a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already
on the market to their intended purpose for an individual patient.
If a manufacturer has no registered offices in Europe, it must appoint an authorized representative in one
of the Member States. The manufacturer could then instruct the authorized representative to take over
some of the conformity assessment procedures. So, the authorized representative would seek the help of a
notified body at the manufacturers request.
In the context of fulfilling its statutory responsibilities, the manufacturer must pay particular attention to its
relations with the subcontractors involved in the design and manufacturer of the product, as well as potential
distributors. A proxy must be appointed if the headquarters of the manufacturer is not the territory of the
European Economic Space or Switzerland.11
2.4.2 Other Parties
Sometimes, in specific situations, other parties are also responsible for putting a device on the market
along with the manufacturer. These parties are:
Authorized Representative of the manufacturer is a legal person established in the EEC who acts as
the face of the manufacturer to the Competent Authorities. More information about the Authorized
Representative, its role, and its responsibilities can be found in MEDDEV 2.5/10.
Subcontractors or suppliers of the manufacturer who may be involved when establishing the conformity of
the device. Information about the control of the suppliers and subcontractors may be found in the NBOG
Best Practice Guide 2010-1.
Distributors can also be involved when:
It is the European-based importer for a non-European manufacturer; and
The distributor can be intermediary for transmitting post-market surveillance information
While it may seem confusing, LNE/G-MED is here to help discern which parties must be involved in a devices
certification. To establish which parties must be involved in your devices certification, contact LNE/G-MED
to speak with a project manager or one of our regulatory experts.
11
See guide MEDDEV 2.5/10 (cf 2.3)
2.5 Role of Notified Bodies

As a third party officially nominated by their respective national authorities, notified bodies issue statutory
certificates that manufacturers need to get their products on the market. As a result, notified bodies are
key to performing the conformity assessments that the Directives establish.
The main task of the notified body is to provide conformity assessment services according to the Directives,
taking into account all of the guides, interpretive material, and standards. These activities include:
Confirmation of the classification of medical device by the manufacturer taking into account the
classification rules defined in the guidelines;
And depending on the class,
The compliance of the medical device (testing, release of manufactured products, ...);
The compliance of the manufacturers quality system (on-site audit);
Assessment of the technical documentation of the medical device, whether systematically, for the
products most at risk, or on a sampling basis for medium-risk products; and
Assessment of critical subcontractors.
The purpose of the quality system audits is to verify that the manufacturer defines, documents, and implements
a coherent set of policies, procedures and practices to control and manage its business. The quality system
must comply with applicable regulatory requirements. Examination of technical documentation and testing
are intended to verify compliance of the medical device to all essential requirements.
A favorable assessment of the quality system and / or technical documentation allows the notified body to
issue CE certificates. These certificates are necessary for the manufacturer to issue a declaration of conformity
prior to placing the device on the market. This is the manufacturers responsibility, that after verifying that
all requirements are met and, where applicable, that all the notified bodys necessary assessments lead to
a CE certificate.
LNE / G-MED is actively involved in the European Commission-sponsored group of Notified Bodies, NB-MED.
NB-MED meets twice each year in Brussels, Belgium, with European Commission and major professional
European medical device manufacturers organizations representatives. During these meetings, practical
issues that can lead to differences of interpretation or action are identified and openly discussed. These
discussions result in consensus statements and recommendations that are written and prepared by task
forces and overseen by the Group of Notified Bodies Recommendations (NBRG).
LNE / G-MED is also a member of the Professional Association Team NB.12 As such, it was one of the five
notified bodies responsible for drafting the Code of Conduct (CoC). The CoC intends to contribute to improving
the implementation of the certification of medical devices under the CE marking by specifying criteria or
jurisdictional elements relating to methods of assessment.
12
http://www.team-nb.org/.
3. What should a manufacturer do before contacting LNE/G-MED or

another Notified Body?
The process outlined in the Directives allows a manufacturer to enter the European market in accordance
with Directives 90/385/EEC, 93/42/EEC and 98/79/EC (see 2.1.) goes through several stages and
involves some choices. Unsuitable choices can lead to extended delays or increased costs required to obtain
certificates and possibly lead to deadlock.
Defining the best approach is of strategic importance.
The main steps are:
1.
2.
3.
4.
5.
6.
Identifying the Manufacturer and, where applicable, its agent, its subcontractors and distributors;
Characterizing the products;
Determining applicable Directives;
Determining product classes for Directives 93/42/EEC and 98/79/EC;
Selecting the most appropriate procedures to determine compliance - Methods of proof
Collecting necessary data for the chosen procedures or, in particular for meeting the demands of
certain horizontal provisions (risk analysis, clinical evaluation, performance evaluation (IVD) etc.);
and
7. Consulting LNE / G-MED once the appropriate procedure is decided.
These milestones are the subject of the sub-chapters below.
3.1 Who is the Manufacturer of the Product?

The definition referenced in 2.4 of this guide enables a company, on the basis of its activity and methods
of marketing the product, to define whether it will be considered the product manufacturer.
It should be noted that if an authorized representative is required, then the manufacturer may instruct his
authorized representative established in the EEA, engaging some of the procedures laid down in Directives,
including Annexes III (EC type examination), IV (EC verification ) VII (EC Declaration of Conformity) and VIII
(Devices for special purposes) of Directive 93/42/EEC or Annex III (EC Declaration of Conformity), V (EC
type examination), VI (EC verification), VIII (Statement for devices intended for performance evaluation) of
Directive 98/79/EC.
10
3.2 Characterizing the Product

Characterizing the product is fundamental because it speaks to which European Directive to use and the
classes of the devices if they are medical devices according to Directive 93/42/EEC.
When the manufacturer establishes that the product meets the definition of an active implantable medical
device (see 90/385/EEC), or a medical device (see 93/42/EEC), or a, in vitro diagnostic medical device (see
98/79/EC), or an accessory, it should respond to certain specific and detailed questions, including:
What is the manufacturers intended use for the device in question, which will be included in the
documents accompanying the device (sales literature, catalog, label, user guide, etc.)?
Does the device depend on a source of energy other than that directly generated by the human
body or gravity for its operation?
Is a drug related to the use of the device? If so, how?
Does the device incorporate products of animal origin?
And any others.
3.3 Determining the Applicable Directives

By applying Article 1 of Directives 90/385/EEC, 93/42/EEC, and 2000/79/EC, manufacturers can
determine which Directives apply to which products. It is also necessary at this stage if another, broader,
directive applies (EURATOM, EMC, machinery etc.). Difficulties may arise for certain borderline products,
like protective equipment (see Directive 89/686/EEC), cosmetics (Directive 76/768/EEC), and especially
drugs (see Directive 2001/83/EC and further guidance).
The guide MEDDEV 2.4 / 1 rev 9 (see 2.3) and the manual Borderline and Classification (see 3.4)
provide guidelines for determining the boundary between medical devices and other products.
3.4 What is the Class of the Medical Device?

3.4.1 Case of Directive 93/42/EEC Medical Devices
The devices relating to Directive 93/42/EEC are broken up into four classes based on risk: I, IIa, IIb, and III.
Medical devices are classified according to the rules contained in Annex IX to this Directive. Parts I and II
of this Annex provide definitions and methods for applying the classification rules. It is imperative to review
the 18 rules of Part III of Annex IX, as it is common that many of these rules are applicable to the same
product. In these cases the devices class is the highest class. These rules are based on the following
criteria:
Duration of use;
Invasive or not, and type of invasiveness;
If the device is re-usable;
Therapeutic or diagnostic;
If the device depends on a source of energy; and
The part of the body in contact with the device.
11
In the MDD, There are five major classification groups:

Rule 1 to 4 : Non-Invasive Devices, but these rules may cover devices in contact with wounds or
biological fluids;
Rule 5 : Devices that are invasive via a body orifice, which includes permanent artificial openings;
Rules 6 to 7 : Devices that are invasive via surgery;
Rule 8 : Long-term implantable and invasive devices;
Rules 9 to 12 : Additional rules for active devices; and
Rules 13 to 18 : Special rules intended for special categories of device, like contact lens solution.
3.4.2 Case of Directive 98/79/CEE In Vitro Diagnostic Devices
Although we are not talking about class, in vitro diagnostic medical devices are divided into 2 groups: IVDs
that fall within Lists A (safety) and B (diagnosis) of Annex II and those that are not on these lists. The guides
MEDDEV 2.1 / 3 rev 3 (see 2.3), MEDDEV 2.1 / 6, MEDDEV 2.17 / 1 rev 2 and the manual Borderline and
Classification (see 2.3) provide guidelines for determining class of medical devices.
3.5 Choice of the Conformity Evaluation Procedures

The conformity evaluation procedures are designed to evaluate compliance with the essential requirements
of the directives. They are the main obligations of the manufacturer for the placing medical devices on the
market in the EEA. Once a device gains compliance according to the procedures, the manufacturer may affix
the CE marking on the device in question and put it on the market.
The choice of the procedure, which is the manufacturer, must be performed as described in:
Article 9 of Directive 90/385/EEC as amended by Article 21.3.2 of Directive 93/42/EEC for active
implantable medical devices (AIMD);
Article 11 of Directive 93/42/EEC for other devices (MD), depending on the class to which the
device in question, a class which was previously determined as described in section 3.4. of this
guide; and
Article 9 of Directive 98/79/EC for medical devices for in vitro diagnosis according to reagent grade
(or related item) to see why, Annex II of the Directive.
12
Choosing the procedure best suited to the manufacturers needs can be guided by the following criteria:
The operation of the business for the organization to ensure the required quality (quality system); and
How to design and manufacture of medical device taking into account the share of outsourced
processes.
For each of the three directives, the evaluation procedure is a combination of the following modules, taking
into account the devices class:
Directive
Modules
90/385/EEC (AIMD)
93/42/EEC (MDD)
98/79/EEC (IVDD)
CE Declaration of
Conformity Full Quality
Assurance System
Design examination
included or not
included
Production Quality
Assurance included
or not included
Annex II
Annex II
Annex IV
CE Type Examination
Annex III
Annex III
Annex V
CE Verification
Annex IV
Annex IV
Annex VI
CE Declaration of
Conformity Production
Quality Assurance
Annex V
Annex V
Annex VII
CE Declaration of
Conformity Product
Quality Assurance
NA
Annex VI
NA
CE Declaration of
Conformity
NA
Annex VII
Annex III
13
The Directives state which procedures are possible with each class. Flow charts showing the procedures are
included in Appendices A and B. Essentially, the conformity assessments have two aspects:
Evaluating the design of the medical device to determine if it meets the requirements of the
Directives; and
Assessing the ability of the manufacturer to mass produce conforming devices and to fulfill its
regulatory obligations.
The manufacturer has the obligation to respect the regulatory process it chose prior to placing the device
on the market and it must be able to demonstrate its approach. Also, depending on the class (or similar for
IVD), it may also be required to verify compliance of this process by a third party: the notified body (see 2.5).
Depending on the class (or similar for IVD) of the device, the choice of different possible procedures
(methods of proof), the association consists of various modules. And these procedures are shown in figures
in Appendices A and B.
The only procedure that doesnt require a Notified body is the CE Declaration of Conformity. This procedure
can only be used for Class I devices that are not sterile or that do not have a measuring function. Even in
these cases, the Notified Body only assesses the points related to securing and maintaining sterile conditions
or metrology.
14
4. Deciphering the Role of the Notified Body

Assessments, by LNE / G-MED are required and performed through the different types of evidence as
described below.
Note: More detailed information on the contents of different dossiers can be obtained from the
Certification Project Managers at LNE / G-MED.
4.1 Design: Examination of the Medical Devices Design Conformity with the Essential
Requirements
The design examination can be, according to the manufacturers choice given the devices class, either:
The responsibility of the manufacturer as part of the Declaration of Conformity (for example, Annex
VII to the MDD or Annex III of 98/79/CE); or
By the Notified Body according to the Product Design Examination or the Type Examination.
4.1.1 Design Examination
This is part of the approval of the complete system of quality assurance module. LNE / G-MED review the
design from a file provided by the manufacturer. The design dossier must contain, in particular, data on the
following:
General description of the medical device;

Design data: characteristics, safety and device performance;
Data on the product realization;
Information provided by the manufacturer;
Risk Management (EN ISO 14971); and
Compliance with the essential requirements
This information provides evidence of product conformity, such as reports of pre-clinical and clinical validation,
quality system-approved procedures, and records related to the design of the device.
This module will result in a Certificate of design examination with a 5-year validity period according to the
Directive. LNE/G-MED will also provide a design report review. The manufacturer must inform LNE / G-MED
of any plan for substantial changes of the products covered.
15
4.1.2 EC Type Examination

LNE/G-MED will certify that a representative sample of the devices production meets the Essential
Requirements. To do so, LNE/G-MED will examine and evaluate the design, manufacturing, and product
performance documentation. It will also conduct inspections and tests necessary to ensure the device
complies with the Essential Requirements. The Directives allow LNE/G-MED to issue an EC Type Examination
certificate for 5 years, and LNE/G-MED will provide an EC Type Examination report. The manufacturer must
inform LNE/G-MED of any plan for any substantial changes to the products that the certificate covers.
4.2 Evaluating the Manufacturers Quality Management System

The manufacturer also chooses the route for the Notified Body, depending on the devices class, to assess
its quality system of manufacturing and regulatory compliance:
Under the manufacturers direct responsibility as part of the Declaration of Conformity (for
example, Annex VII in Directive 93/42/CEE or Annex III in Directive 98/79/CE);
By the Notified Body as part of the Complete Quality Assurance System, Production Quality
Assurance System, or Product Quality Assurance System assessments; or
By the Notified Body as part of the EC Verification, done on a unitary or sampling basis.
4.2.1 Complete Quality Assurance System
In the Complete Quality Assurance System, LNE/G-MED will evaluate the manufacturers quality system for
the products that will be covered under the certificate, and it will ensure the system is continuously applied.
Depending on the classes, point 4 of Annex II, Design Review, may not apply. According to the class of the
device, the part described in point 4 of Annex II Design Review does not apply. LNE/G-MED will perform all
the audits annually as part of the certification cycle, and the manufacturer must inform LNE/G-MED of any
substantial changes for the device or the covered products.
4.2.2 Production Quality Assurance
This module involves the approval and monitoring by LNE / G-MED, the quality assurance system for
manufacture and final inspection of the products. LNE/G-MED will approve and monitor the manufacturers
quality management system for the manufacture and final inspection of the product. To do so, LNE/G-MED
will evaluate the manufacturers quality management system for the products and ensure the system is
applied continuously. LNE/G-MED will also perform any necessary audit. The manufacturer must inform
LNE/G-MED of any substantial changes to the approved system or the product coverage.
4.2.3 Product Quality Assurance
LNE/G-MED will approve and monitor the manufacturers quality management system for the final inspection
of the products. To do so, LNE/G-MED will evaluate the manufacturers quality management system for the
products and ensure the system is applied continuously. LNE/G-MED will also perform any necessary audit
annually as part of the certification cycle. The manufacturer must inform LNE/G-MED of any substantial
changes to the approved quality system or the product scope.
16
4.3 Evaluating the Conformity of Each Lot of the Product

4.3.1 EC Verification
LNE/G-MED will make examinations and tests by checking every product or statistical control of a homogenous
sample of each bath (batch sampling) to ensure the device complies with the Essential Requirements. LNE/
G-MED will then issue a certificate.
4.4 Verification of Manufactured Products (The Only Assessment Procedure Under the
IVDD)
For IVDs that are in Annex II, List A of the IVDD, this procedure is mandatory. The manufacturer will give
LNE/G-MED the relevant batch reports immediately after the examinations and tests are performed. The
manufacturer will also provide to LNE/G-MED the samples of the batches it produced. If LNE/G-MED detects
any abnormalities in the samples that reveal a non-compliance with the Essential Requirements, LNE/GMED must notify the manufacturer within an agreed-upon timeframe. The manufacturer cannot market the
affected lots.
4.5 Case of Devices Incorporating a Medicinal Product

Where a device incorporates, as an integral part, a substance which, if used separately, may be considered
to be a medicinal product, the Notified Body must, in addition, consult one of the Competent Authority for
drugs appointed by the Member States or the European Medicines agency (EMA). This consultation consists
of an assessment of the aspects linked to quality and safety of the combined devices, as well as the risk/
benefits profile as part of an evaluation of EC type or design examination. The evaluation of the usefulness
of the drug substance is the responsibility of the Notified Body.
More information can be provided by the MEDDEV Guidance 2. 1/3 rev 3.13
13
http://ec.europa.eu/health/medical-devices/files/meddev/2_1_3_rev_3-12_2009_en.pdf
17
5. Demonstrating the Conformity to the European Regulatory

Scheme: Some Key Principles
5.1 Demonstrating Product Conformity to the Essential Requirements
5.1.1 Essential Requirements
All the directives refer to the Essential Requirements as the technical conditions to which medical devices
must comply in order to be put on the market. Annex I of these directives describe the Essential Requirements.
Article three of Directive 93/42/EEC states, for instance, The devices must meet the essential requirements
set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.
Part I of Annex I describes the general requirements applicable to any medical device, including the risk
management and clinical evaluation. Part II of this annex sets out the essential requirements, which are
grouped according to the following themes:
MD & AIMD
IVDD
Same Essential Requirements as MD/AIMD, also includes

rrequirements for self-testing devices for self-testing
Chemical, physical, and biological properties;

Infection and microbial contamination;
Construction and environmental properties;
Devices with a measuring function;
Protection against radiation;
Requirements for medical devices connected to or
equipped with an energy source;
Information supplied by the manufacturer
5.1.2 Risk Management

Included in the Essential Requirements is the concept that a manufacturer should eliminate or reduce risks
as far as possible while designing and manufacturing the device. Manufacturers catalog these risks and
the actions they take to eliminate and minimize these risks in a Risk Management File, part of the technical
documentation for the device. The EN ISO 14971 standard is the European Harmonized Standard for risk
management.
5.1.3 Clinical Evaluation
The clinical evaluation is the process that the manufacturer applies to identify, select, appraise, and critically
analyze the clinical data to meet the applicable essential requirements of the MDD and the AIMDD. Clinical
evaluations are not used for IVDs. There are four MEDDEVS that manufacturers can use to guide them in
collecting the data and reporting on their clinical evaluations:
MEDDEV 2.7/1 rev. 3 Clinical Evaluation: Guide for manufacturers and notified bodies
MEDDEV 2.7/4 Guidelines on Clinical Investigations: a guide for manufacturers and notified
bodies
MEDDEV 2.12/2 rev. 2 Post Market Clinical Follow Up Studies
18
5.1.4 European Harmonized Standards

Because of the general nature of the essential requirements, as they apply to all medical devices, and the
difficulty of guaranteeing a common approach from all manufacturers and Notified Bodies, the New Approach
attributes a particular role and significance to standards. Where the European essential requirements
provide the goals for proving a medical devices safe and effective performance, the harmonized standards
provide methods for reaching those goals. Their application is not mandatory for placing on the market in
the EEA, however the compliance with all European Harmonized Standards is a presumption of conformity
with the essential requirements.
The bodies responsible for developing and ratifying these standards at the European level are CEN and
CENELEC. Their national equivalents for France are AFNOR and UTE.
5.1.5 Common Technical Specifications
Specifically, Directive 98/79/EC introduces (exclusively) for the most critical devices those mentioned
in Annex II List A and, if necessary, List B the concept of Common Technical Specifications. These
specifications establish appropriate performance evaluation and re-evaluation criteria, batch release criteria,
reference methods, and reference materials.
Experts of Member States Authorities set up these Common Technical Specifications, which were officially
adopted and published in the OJEU of 3 February 2009.
Manufacturers are, as a general rule, required to comply with the CTS. If, for a duly justified reason they
dont comply with those specifications, they must adopt solutions of an equivalent level.
5.2 Demonstrating Conformity of the Quality System

The European directives require the manufacturer to implement a quality management system for some
classes of MD or IVDMD. The objectives and structure of the QMS are described within the corresponding
annexes (see 3 and 4).
EN ISO 13485 (Medical devices - Quality management systems - Requirements for regulatory purposes)
is the European Harmonized standard on this matter. Specific attention should be paid to the European
foreword of this standard. Indeed, Annexes ZA, ZB and ZC of EN ISO 13485:2012 show the comparison
between the chapters of the standard and the requirements of the annexes of the Directives.
More information about what a QMS is expected to be may be found in the following guidance documents:
NBOG BPG 2010-1 and NBOG BPG 2010-2 (http://nbog.eu/2.html).
19
6. Maintaining CE Marking
This chapter describes the measures taken by the manufacturer, as well as the obligations laid on the
manufacturer, for the purpose of maintaining the CE marking for given devices over time.
Every device placed on the European market must conform to the essential requirements. Indeed, the
concepts of placing on the market and putting into service refer to each individual product and not to a
type of device.
This means that in this regard, two objectives must be met:
Objective 1:
Controlling changes in the model.

When the design of a model is changed, or when its manufacture is changed, the
change must not have the effect of removing its conformity with the essential
requirements.
Objective 2:
Each copy must be the same as the model.

Each copy of a model whose design has been approved by a Notified Body through
application of one of the measurement procedures laid down in the directives or,
where applicable, whose design has been declared in conformity by the manufacturer
himself, must be made in such a way that it remains identical to the model.
For this reason, the directives contain provisions that are intended to ensure the permanent
maintenance of this conformity.
6.1 Full quality assurance system

6.1.1 If the examination of the design of the product has been done
Changes to the approved design must receive further approval from the Notified Body which issued the EC
design-examination certificate wherever the changes could affect conformity with the essential requirements
of the directive or with the conditions prescribed for use of the product.
In addition, for diagnostic in vitro medical devices listed in annex II, list A, the manufacturer shall inform,
immediately the Notified Body if it has obtained information about changes to the pathogen and
markers of infections to be tested, in particular as a consequence of biological complexity and
variability. In this connection, the manufacturer shall inform the Notified Body whether any such a
change is likely to affect the performance of the concerned device.14
The manufacturer is responsible for declaring design changes to the Notified Body when these changes
meet the conditions referred to above.
14
Directive 98/79/EC annex IV, point 4.5
20
It may be said that if one or other of the following circumstances were to arise, but not limited to, a declaration
should be made:
Change in the intended purpose (indication or use intended by the manufacturer);

Change in design having an impact on the results of the risk analysis or on the clinical data;
Change in design having an impact on the declared performances;
Substantial change in the instructions for use.
6.1.2 General cases

The manufacturer must inform the Notified Body that approved the quality system of any plan for substantial
changes to the quality system or the product range covered.
In addition, to check that the manufacturer applies his approved quality system permanently to all products
placed on the market which are supposed to have originated in this system, the directives stipulate that
surveillance audits shall be performed. LNE/G-MED performs this surveillance annually.
In addition, the Notified Body may pay unannounced visits to the manufacturer. At the time of such visits,
the Notified Body may, where necessary, carry out or ask for tests in order to check that the quality system
is working properly.
6.2. Production quality assurance

The content of 6.1.2 above applies here, though its bearing is limited to the nature of the quality system
initially approved (i.e. without taking control of design into account).
6.3. Product quality assurance

The content of 6.1.2 above applies here unchanged, though its bearing is limited to the nature of the
quality system initially approved.
6.4. EC type-examination
Changes to the approved product must receive further approval from the Notified Body that issued the EC
type-examination certificate wherever the changes could affect conformity with the essential requirements
of the directive or with the conditions prescribed for use of the product.
As in the case of EC type-examination, the applicant, who here may be the manufacturers representative,
is responsible for declaration.
The extent of change in a product which may require such a declaration is not specified in the directives, but
in this regard the conclusions of paragraph 6.1.1 of this guide may be applied.
In addition, for diagnostic in vitro medical devices listed in annex II, list A or list B, the manufacturer shall
inform the Notified Body on changes of pathogen agent and infection markers, as stipulated in the paragraph
6.1.1 of this guide.
21
6.5 EC verification
Note: This procedure must not be confused with the verification of manufactured products specific to
certain in vitro diagnostic devices.
In this procedure, the Notified Body intervenes either for each copy placed on the market (unit verification),
or for each batch released (statistical verification). The question of the maintenance, during the time, of CE
marking conditions does not occur in this case.
However, for devices placed on the market in a sterile condition, the conditions for maintaining CE marking
as described in 6.2 of this guide apply for aspects regarding the securing and maintenance of sterility.
6.6 EC declaration of conformity

Here, the obligations the manufacturer has consist of keeping up-to-date technical documentation which is
made available to the national authorities for inspection for a period five years at least after the manufacture
of the last product marketed.
However, as before, for devices placed on the market in a sterile condition, the conditions for maintaining
CE marking as described in 6.2 of this guide apply for aspects regarding the securing and maintenance of
sterility.
6.7. Verification of manufactured products

In the case of in vitro diagnostic medical devices covered by annex II, list A, the manufacturer shall
forward to the Notified Body the relevant reports on the tests carried out on each batch of manufactured
devices. Furthermore, the manufacturer shall make the samples of manufactured devices or batches of
devices available to the Notified Body in accordance with pre-agreed conditions and modalities.
The manufacturer may place the devices on the market, unless the Notified Body communicates to the
manufacturer within the agreed time-frame but not later than 30 days after reception of the samples, any
other decision, including in particular any condition of validity of delivered certificates.
22
7. Conclusion
Marketing medical devices in Europe requires CE Marking and following the applicable regulations and
standards for the devices. Forming a deep understanding the regulations is key to forming the regulatory
strategy for the devices entry into the European market. This Guide, along with the expertise at LNE/G-MED,
gives manufacturers this deep understanding of the regulations for creating an effective strategy. LNE/GMED, as a Notified Body, enjoys a front-row seat to the European medical devices regulatory scheme and can
help to open the European market for medical device manufacturers. Manufacturers can use this expertise
and experience for their benefit by choosing LNE/G-MED as their Notified Body.
23
Annexes
Annex A: Conformity Assessment Routes for Medical Devices under Directives 93/42/
EEC (MDD) and 90/385/EEC (AIMDD)
Class I Medical Devices
24
Class IIa Medical Devices
25
Class IIb Medical Devices
26
Class III Medical Devices and Active Implantable Medical Devices (AIMD)
27
Annex B: Conformity Assessment Routes for In Vitro Diagnostic Medical Devices under
Directive 98/79/EEC (IVDD)
Devices Referred to in Annex II, List A
28
Devices Referred to in Annex II, List B
Self-Testing Devices (Except those in Annex II)

General IVDs
29

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CE MARKING OF MEDICAL DEVICES

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CE MARKING OF MEDICAL DEVICES

5. Demonstrating the Conformity to the European

2. The Regulatory Scheme for Medical Devices in Europe 4

5.1 Demonstrating Product Conformity

2.1 Context .................................................................................... 4

to the Essential Requirements .................................................... 18

2.1.1 Particular Case of the Common Technical Specifications 5

5.1.1 Essential Requirements ....................................................... 18

2.2 To which products do the Directives apply? ......................... 5

5.1.2 Risk Management ................................................................ 18

2.3 What can a manufacturer do when the regulatory texts dont

5.1.4 European Harmonized Standards ....................................... 19

answer his or her questions Where to find interpretations?

5.1.5 Common Technical Specifications ...................................... 19

5.2 Demonstrating Conformity of the Quality System ................ 19

2.4 Who is responsible for placing medical devices

6. Maintaining CE Marking ................................................. 20

2.4.1 Manufacturer ........................................................................ 8

6.1 Full quality assurance system ............................................... 20

2.4.2 Other Parties ........................................................................ 8

2.5 Role of Notified Bodies .......................................................... 9

6.1.1 If the examination of the design

3. What should a manufacturer do before contacting

6.2. Production quality assurance ............................................... 21

3.4.1 Case of Directive 93/42/EEC Medical Devices .............. 11

4. Deciphering the Role of the Notified Body .................... 15

4.1 Design: Examination of the Medical Devices Design

Annex A: Conformity Assessment Routes for Medical Devices

Conformity with the Essential Requirements.............................. 15

under Directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD)

4.1.1 Design Examination ............................................................. 15

4.2 Evaluating the Manufacturers

Class I Medical Devices ................................................................. 24

4.2.2 Production Quality Assurance ............................................. 16

Annex B: Conformity Assessment Routes for In Vitro Diagnostic

4.2.3 Product Quality Assurance .................................................. 16

Medical Devices under Directive 98/79/EEC (IVDD) ................. 28

4.3 Evaluating the Conformity of Each Lot of the Product ......... 17

Devices Referred to in Annex II, List A .......................................... 28

Devices Referred to in Annex II, List B .......................................... 29

4.4 Verification of Manufactured Products

Self-Testing Devices (Except those in Annex II) ............................ 29

(The Only Assessment Procedure Under the IVDD) .................... 17

General IVDs ................................................................................... 29

4.5 Case of Devices Incorporating a Medicinal Product ............ 17

CE MARKING OF MEDICAL DEVICES

1. Introduction to the guide

CE MARKING OF MEDICAL DEVICES

2. The Regulatory Scheme for Medical Devices in Europe

CE MARKING OF MEDICAL DEVICES

Medical Devices Incorporating a Human Blood Derivative or Human Plasma (2000/70/EC of 16

2.2 To which products do the Directives apply?

93/42/EEC Art. 1(2)(a).

CE MARKING OF MEDICAL DEVICES

98/79/EC Art. 1(2)(b).

CE MARKING OF MEDICAL DEVICES

2.4 Who is responsible for placing medical devices on the market?