SUPPLEMENT
How are medical devices regulated
in the European Union?
Elaine French-Mowat1 • Joanne Burnett2
1
Guildford Medical Device Evaluation Centre (GMEC), The Royal Surrey County Hospital, Egerton Road, Guildford, Surrey
GU2 7XX
2
NICE – MTEP, Level 1A City Tower Piccadilly Plaza, Manchester M1 4BD, UK
Correspondence to: Elaine French-Mowat. Email: elainefrench-mowat@btconnect.com
DECLARATIONS Background • In Vitro Diagnostic Medical Device Directive
(IVDMDD 98/79/EC).3
Competing interests
The Medical Technology Evaluation Programme
The authors have no These have been supplemented since by several
(MTEP) within the National Institute for Health
competing interests and Clinical Excellence (NICE) was set up in 2009; necessary updates, due to new and emerging tech-
to declare. All this is a programme focusing specifically on the selec- nologies which have challenged the current frame-
articles were tion and evaluation of new or innovative medical work, highlighted gaps and pointed to a certain
originally technologies (including devices and diagnostics). scarcity of expertise.4 The MDD (article 1.2a)
commissioned by One of the requirements to enable a product to define a Medical Device as:
NICE from be evaluated by the MTEP is that the device is CE ‘Any instrument, apparatus, appliance, material
independent marked or it will be CE marked within twelve or other article, whether used alone or in combi-
months. This report was produced to describe the nation, including software necessary for its proper
External
CE marking process for different categories of application intended by the manufacturer to be
Assessment Centres
medical technology and the types/quality/quantity used for human beings for the purpose of:
(EACs) to address
of evidence that are required for each category.
areas of interest to • Diagnosis, prevention, monitoring, treatment
the Medical or alleviation of disease;
Summary
Technologies • Diagnosis, monitoring, treatment, alleviation of
Evaluation Medical devices cannot be placed on the European or compensation for an injury or disability;
Programme (MTEP, market without conforming to the strict safety require- • Investigation, replacement or modification of
originally known as ments of the European Union; one of these require- the anatomy or of a physiological process;
Evaluation Pathways ments is the affixation of the CE conformity mark. • Control of conception.
EP). The EACs were This article is an overview of the CE marking
process only; it is not a document that should be and which does not achieve its principal intended
engaged under a
referred to on its own. All manufacturers wishing to action in or on the human body by pharmacologi-
contract to NICE
gain a CE mark should refer to the official documents. cal, immunological or metabolic means, but which
Funding may be assisted in its function by such means.’
NICE Legislation
The CE mark
Ethical approval Collectively known as the Medical Device Direc-
Not applicable tive (MDD), this core legal framework consists of This is a conformity mark which all European
three directives that regulate the safety and mar- medical devices must have before they can be mar-
Guarantor
keting of medical devices in Europe and came keted. It is seen as a declaration by the manufac-
Chris Pomfrett turer that the product meets all the appropriate
into effect in the 1990s. The three directives are the:
Contributorship
provisions of the relevant legislation including
Elaine
• Active Implantable Medical Device Directive those related to safety and, where required, has
(AIMDD 90/385/EE);1 been assessed in accordance with these. Article
French-Mowatt
• Medical Device Directive (MDD 93/42/EEC);2 1, MDD 93/42/EEC, states:
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CE marking process
wrote the first (1) ‘Devices, other than devices which are ensure that conformity assessment procedures are
version of the custom-made or intended for clinical investi- completed according to the relevant criteria. The
manuscript while gations, considered to meet the essential authorized representative, designated by the manu-
working for GMEC, requirements referred to in Article 3, must facturers, is legally responsible for compliance with
an independent bear the CE marking of conformity when the regulations and acts as the first point of contact
academic External they are placed on the market. for the EU authorities.
Assessment Centre
(2) The CE marking of conformity, as shown in It is up to the manufacturer to ensure that their
Annex XII, must appear in a visible, legible and product complies with the essential requirements
working under
indelible form on the device or its sterile pack, of the relevant EU legislation. A general overview
contract to NICE.
where practicable and appropriate, and on the of the CE marking process is:
Joanne Burnett
instructions for use. Where applicable, the CE
extensively edited marking must also appear on the sales packaging. • Check which directives and Annexes apply;
and updated the It shall be accompanied by the identification • Choose conformity assessment procedure/route;
manuscript in order number of the notified body responsible for • Prepare design dossier (for required devices);
for it to be suitable implementation of the procedures set out in • Prepare technical documentation;
for publication. Annexes II, IV, V and VI. • Prepare declaration of conformity;
Joanne Burnett is a (3) It is prohibited to affix marks or inscriptions • Submit to notified body (NB), if applicable, for
Technical Analyst which are likely to mislead third parties with certification;
working in the regard to the meaning or the graphics of the • Register with CA (by manufacturer or an auth-
CE marking. Any other mark may be affixed orised representative);
Medical
to the device, to the packaging or to the • Apply CE marking and market product;
Technologies
instruction leaflet accompanying the device, • Implement vigilance and post market surveillance
Evaluation
provided that the visibility and legibility of by monitoring safety and efficiency, and review-
Programme (MTEP) ing experience of use and any action required.
the CE marking is not thereby reduced.’
of NICE.
Dr Chris Pomfrett The CE conformity mark consists of the initials Irrespective of the class of the device, all devices
does not claim ‘CE’ taking the following form: must:
authorship, but The various components of the CE marking
acted as supervising must have substantially the same vertical dimen- • Meet the essential requirements, including the
editor for this work in sion, which may not be less than 5 mm, although requirements regarding the information to be
this minimum dimension may be waived for supplied by the manufacturer;
NICE. Dr Chris
small-scale devices. • Evaluate clinical efficacy and any side effects, if
Pomfrett is a
The initials “CE” do not stand for any specific applicable by means of a pre-clinical and clini-
Technical Adviser
words; it is a symbol that is seen as a declaration cal evaluation;
working in MTEP at • Be subject to the reporting requirements under
by the manufacturer that the product meets all the
NICE the medical device vigilance system;
appropriate provisions of the relevant legislation.
Acknowledgments This includes those related to safety and it shows • Be CE marked (except accepted exemptions);
that, where required, the device has been assessed • Be registered with the CA where the manufac-
None
in accordance with the appropriate procedures. turer (or the authorised representative) has a
The CE mark also means that the product can be registered place of business.
freely marketed anywhere in the European Econ-
omic Area (EEA) without further control. Device classification
All medical devices are placed into one of four
Overview of CE marking process graduated categories, using the classification
rules listed in Directive 93/42/EEC Annex IX.2 It
Competent Authorities (CA), Notified Bodies (NB) is considered more feasible, economically and jus-
and authorized representatives are all involved in tifiably, to categorize medical devices rather than
the CE marking process. CA’s exist in each Euro- all of them being subject to the rigorous confor-
pean Member State and are nominated by each gov- mity assessment procedures.
ernment to monitor and ensure compliance with its The categories are Class I (including Is & Im),
provisions of the MDD. The CA designates a NB to Class IIa and IIb and Class III, with Class III
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Journal of the Royal Society of Medicine
ranked as the highest. The higher the classification of Conformity. The manufacturer ensures and for-
the greater the level of assessment required by mally declares, via a written statement, that the pro-
NBs. It is the intended purpose of the device that ducts meet the applicable provisions of the Directive.
determines the classification and not the particu-
Class IIa
lar technical characteristics. Considerations for
The manufacturer declares conformity with the
classification include the duration of contact with
provisions of the Directive and Regulations
the body, degree of invasiveness and local versus
(Annex VII) and ensures that the products
systemic effect. The highest possible class applies
comply with relevant essential requirements.
if a device can be classified according to several
However, for Class IIa products, this declaration
rules. Table 1 has details for each class.2
must be backed up in all cases with conformity
Conformity assessment procedure assessment by a NB using Annex II, IV, V or VI.
A conformity assessment procedure demonstrates Class IIb
that the device complies with the requirements of Manufacturers of Class IIb devices may also
Directive 93/42/EEC.2 Compliance is stated by choose the full quality assurance route (Annex II)
establishing a Conformity Declaration. The classi- including assessment by a NB of the technical
fication of the device dictates the appropriate con- documentation for at least one representative
formity assessment procedure. In some cases the sample for each generic device group for compli-
manufacturer has a choice of conformity route. ance with the Directive (Annex II section 7).
The conformity assessment routes are shown in
Class III
Figures 1, 2, 3 and 4.
This route to conformity is similar to those for
Class I Class IIb devices but additionally requires the
This route is self-declaration or self-certification and manufacturer to submit the design dossier to the
is described in Annex VII Module A, EC Declaration NB for approval under audit of the full quality
Table 1
Examples of product classification
Classification Risk Description Examples
General controls Hospital beds, bed pans
I Sterile (Is) Low Most non-invasive devices that do Sterile plasters
not interact with the body.
Measuring (Im) Thermometers, weighing scales.
IIa Special controls required: may Medium Exchange energy with a patient in a Powered wheelchairs, hearing aids,
include special labelling, therapeutic manner or are used to ultrasonic diagnostic equipment
mandatory performance diagnose or monitor medical
standards & post-market conditions. Generally invasive but
surveillance limited to natural orifices, if
hazardous to a patient then it
becomes a class IIb
IIb Special controls (as IIa) Medium Most surgically invasive/active Infusion pumps, ventilators, surgical
devices partially or totally lasers
implantable in the body. May
modify composition of body fluids.
III Pre-market approval is the High Support or sustain human life and Many implants: vascular &
required process of scientific are of substantial importance in neurological, replacement heart
review to ensure the safety and preventing impairment of human valves, silicone gel-filled breast
effectiveness of these health, or which present a implants, and implanted cerebella
potential, unreasonable risk of stimulators
illness or injury. Device that
connects directly with the Central
Circulatory System or CNS, or
contains a medicinal product.
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CE marking process
Figure 1
Class I conformity assessment procedures
assurance system (Annex II) and do not allow the documentation, the design dossier (if applicable)
Annex VI option. and the NB decisions and reports/certificates
Active implantable medical devices (AIMD) must be kept at the disposal of the CA.
and in vitro diagnostic medical devices (IVD) are As part of the compliance strategy, manufac-
also subject to conformity procedures. turers also have to provide evidence of basic
good manufacturing practice (GMP).5,6 The GMP
Required documentation or Formal Quality System applies to devices in
For five years (15 years for implantable devices) Class Is, Im, IIa, IIb and III, AIMDs and IVDs
after the final production of the device, the listed in Annex II and those for self-testing. Basic
declaration of conformity, the technical Class I medical devices (non-measuring and not
Figure 2
Class IIa conformity assessment procedures
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Journal of the Royal Society of Medicine
Figure 3
Class IIb conformity assessment procedures
supplied sterile) and general IVDs (IVDs that are point of contact if there are any problems to be
not for self-testing and/or do not appear in investigated. It must be kept in the technical file.
Annex II) do not need a formal or full quality The declaration of conformity should have the
system, basic GMP is sufficient. name and address of manufacturer, identification of
the product allowing traceability, list of relevant direc-
Declaration of conformity
tives, declaration statement, name and position/job
This document is required for all medical
title of person signing. This should be someone
devices, AIMDs and IVDs, and is a written state-
with enough responsibility to ensure the declaration
ment produced by the manufacturer to formally
is true which is affirmed by their signature and date.
declare that a named product conforms to the
appropriate directives. If more than one Direc- Technical documentation and design
tive is applicable then these should all be listed dossier
on the declaration. It also identifies who is These have to be produced to allow the assess-
responsible for a product and provides a first ment of the conformity with the essential
Figure 4
Class III conformity assessment procedures
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CE marking process
requirements of the Directive; the level and com- surveillance, inspection, test and clinical evalu-
plexity of detail will depend on the conformity ation assessment reports or an approval of
assessment route. Overall it should cover the changes decision as outlined below.
design, manufacture and intended operation of For basic class I devices, only the declaration of
the product. The ‘operation’ of the product includes conformity is required before affixing the CE
installation, preparation for use, pre-use checks and marking and placing the device on the market. All
maintenance, calibration and servicing as appropri- other devices are required to be certified by third
ate to the particular medical device. Data has to be parties. These third parties are laboratories; inspec-
provided that is sufficient to demonstrate that the tion and the certification bodies are the NBs. Follow-
device will perform safely and achieve the stated ing a successful conformity assessment, the NB
performance claims for its intended use. The techni- issues an EC certificate indicating the route to certi-
cal documentation must include: fication. The manufacturer, having signed a declara-
tion of conformity, can then legally place the CE
• A general description of the product, including marked product on the European market.
any variants planned and its intended use(s);
• Design drawings, methods of manufacture Quality of evidence required
envisaged and diagrams of components, sub-
Technical files and design dossiers are viewed as
assemblies, circuits;
controlled documents and as such should be
• The descriptions and explanations necessary to
part of the manufacturer’s quality system with
understand the above mentioned drawings and
systems in place to update.
diagrams and the operations of the product;
The manufacturer should be able to demon-
• Results of the risk analysis and a list of the har-
strate where and how the documentation is held
monized standards, applied in full or in part,
and maintained. The pages should be numbered
and descriptions of the solutions adopted to
and the information be presented in an organized,
meet the essential requirements;
concise and coherent manner to facilitate review
• In the case of products placed on the market in
by the NB, if applicable, as conclusions and
a sterile condition, description of the methods
synopsis. Tables and flow charts are effective
used and the validation report;
mechanisms to provide summary results. Gener-
• The results of the design calculations and of the
ally, documents that demonstrate compliance
inspections carried out;
with the essential requirements are summarized
• The solutions adopted to ensure that the design
in the text of the technical file or design dossier
and construction conform to safety principles;
and included as an attachment or appendix.
• The pre-clinical evaluation;
• The clinical evaluation in accordance with Medical technology not requiring
Annex X; a CE mark
• The label and instructions for use.
Although the rules will adequately classify the
The technical documentation and quality manage- vast majority of existing devices, a small number
ment system (QMS) are audited annually by the of products may be more difficult to classify. If a
NB. The NB must also periodically carry out manufacturer is unsure how its devices should
appropriate inspections and assessments to be classified, it should first consult a NB. If
ensure the manufacturer applies the approved doubts remain or there is a disagreement with
QMS and produce a report. They may also carry the NB, the relevant CA should be approached
out unannounced visits to check that the QMS is in accordance with Article 9 of Directive 93/42/
working properly and produce a report on their EEC.2 Exemptions from CE marking include:
findings. The manufacturer must inform the NB
of any changes applied to the QMS. • Custom-made devices;
• Devices intended for clinical investigation;
Notified bodies evidence • Health protection – urgent unusual circum-
Any reports or decisions issued by the NB should stances, humanitarian use;
be kept in the technical file. These may include • In-house use.
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Other relevant legislation Council of 27th October 1998 on in vitro diagnostic medical
devices. 98/79/EC. 1998
4 Council of the European Communities. Directive of the
Each medical device can only be placed on the European Parliament and of the Council of 5th September
market and/or put into service when the product 2007 amending Council Directive 90/385/EEC on the
complies with the provisions of all applicable approximation of the laws of the Member States relating to
active implantable medical devices, Council Directive 93/
directives and when the conformity assessment
42/EEC concerning medical devices and Directive 98/8/EC
has been carried out in accordance with all the concerning the placing of biocidal prodcuts on the market.
directives. As a result, several directives may 2007/47/EC. 2007
have to be taken into consideration for one 5 International Organization for Standardization. Medical
devices – Quality management systems – Requirements for
product; these include: General Product Safety
regulatory purposes. ISO 13485:2003. 2003
Directive (92/59/EEC),7 Medical Electrical Equip- 6 International Organization for Standardization. Quality
ment (BS EN 60601) and the Directive of Electro- management systems – Requirements. ISO 9001:000. 2000
magnetic Compatibility (2004/108/EC).8 7 Council of the European Communities. Council Directive
of 29 June 1992 on general product safety 92/59/EEC. 1992
8 European Parliament and the Council of the European Union.
References Directive of the European Paliament and of the Council of 15
1 Council of the European Communities. Council Directive of December 2004 on the approximation of the laws of the
20th June 1990 on the approximation of the laws of the Member States relating to electromagnetic compatibility and
Member States relating to active implantable medical repealing Directive 89/336/EEC. 2004/108/EC. 2004
devices. 90/385/EEC 2007
2 Council of the European Communities. Council Directive of
14th June 1993 concerning medical devices. 93/42/EEC. 2007 Useful website
3 European Parliament and the Council of the European Medicines and Healthcare Regulatory Authority (MHRA)
Union. Directive of the European Parliament and of the http://www.mhra.gov.uk
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