To download the complete document for free, visit: http://www.ttopstart.com/news/spottlight-report-certification-and-registration-of-medical-devices-on-the This publication provides an overview of the regulations and legislations with regard to commercialisation of medical devices. The product category of medical devices includes in vitro diagnostics (IVDs), active implantable medical devices (AIMDs) as well as medical software. In Europe, market approval for medical devices is achieved via a decentralised procedure of CE marking, whereby quality and safety is addressed, and registration of the product. This procedure is in compliance with European regulations and with national legislation of the countries in which market entry is planned. In the US, market approval is granted by the FDA upon assessment of quality, safety and effectiveness. Though complex, the decentralised European system seems to speed up the access to medical devices at least three years as compared to the central system in the US or systems elsewhere in the world. The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulative procedures for specific classes of medical devices and between the authorities and regulations in Europe and the US. By summarising the build-up of a technical file, the significance of a quality management system (QMS), the selection of Annexes, the advantages of adherence to ISO standards, the use of MEDDEV guidelines and the procedures for standalone software and IVDs specifically, we aim to offer a guide through dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.

1. October 2013
Certification and
registration
Medical devices on the
European market

3. Certification and registration Medical devices on the European market 3
Certification and
registration
Certification and
registration
Medical devices on the
European market

4. Certification and registration Medical devices on the European market4 ttopstart
This publication provides an overview of the regulations and legislations
with regard to commercialisation of medical devices. The product category of
medical devices includes in vitro diagnostics (IVDs), active implantable medi-
cal devices (AIMDs) as well as medical software. In Europe, market approval
for medical devices is achieved via a decentralised procedure of CE marking,
whereby quality and safety is addressed, and registration of the product.
This procedure is in compliance with European regulations and with national
legislation of the countries in which market entry is planned. In the US,
market approval is granted by the FDA upon assessment of quality, safety and
effectiveness. Though complex, the decentralised European system seems to
speed up the access to medical devices at least three years as compared to the
central system in the US or systems elsewhere in the world.
The information provided here informs start-ups, spin-offs and biotech
companies about the differences in regulative procedures for specific classes
of medical devices and between the authorities and regulations in Europe
and the US. By summarising the build-up of a technical file, the significance of
a quality management system (QMS), the selection of Annexes, the advan-
tages of adherence to ISO standards, the use of MEDDEV guidelines and the
procedures for standalone software and IVDs specifically, we aim to offer a
guide through dense regulative and legislative landscape. These insights can
be used to design the optimal market introduction strategy for your medical
device.
Executive
summary

5. Certification and registration Medical devices on the European market 5
Contents
Scope
European legislation on medical devices
Medical devices
Medical software
In vitro diagnostic medical devices
Active implantable medical devices
CE certification
Notified Bodies
Preliminary procedure
CE certification procedure
QMS
Technical file
Investment
Follow-up and extension
Registration
Eudamed
NOTIS
Registration and market approval in Europe versus US
Importing US products into Europe
Exporting EU products into the US
Conclusion
Appendix I
Appendix II
Appendix III
6
7
9
10
10
11
12
12
12
13
13
14
15
15
16
16
16
17
17
17
18
19
20
21

6. Certification and registration Medical devices on the European market6 ttopstart
Scope
Modern medicine strongly depends on the use of medical devices for purpos-
es of both care and cure. In contrast to pharmaceutical products, their primary
mode of action is not pharmacological, immunological or metabolic. Medical
devices range from large capital hospital fixed equipment, through high-
technology implants, surgical and monitoring equipment, to more familiar
products such as wheelchairs, sticking plasters, syringes, incontinence aids
and spectacles. The product category of medical devices falls apart in three
classes: medical devices (making up about 80% of the total including medical
software), in vitro diagnostics (IVDs) and active implantable medical devices
(AIMDs). Examples of IVD devices include reactors, instruments or other
devices used for examining sample material from the human body, including
excreted material, for providing information to ensure a correct patient diag-
nosis. An AIMD is any medical device which is totally or partially introduced
(surgically or medically) into the human body and which is intended to remain
after the procedure. Common examples are pacemakers, defibrillators, coch-
lear implants, insulin pumps and neurostimulators.
Market introduction of medical devices is preceded by certification and reg-
istration, which are accomplished in compliance with national and interna-
tional regulations. Certification by placing the CE-mark is a requirement for
selling most medical products and equipment in the EU. For certification, each
country has appointed one or more authorities to perform the certification
procedure. In Europe, these authorities are named notified bodies (NBs) and
operate independently of each other. The objective of NBs is to assess the
performance of medical devices in terms of performance and safety, while
evidence of effectiveness is not required at the stage of certification.

7. Certification and registration Medical devices on the European market 7
In Europe, registration of medical devices is subject to harmonised European
directives established in the 1990s. The core legal framework consists of three
directives: Directive 90/385/EEC regarding active implantable medical devices
(AIMDD 90/385/EC), Directive 93/42/EEC regarding medical devices (MDD
93/42/EC) and the Directive 98/79/EC regarding in vitro diagnostic medical
devices (IVDD 98/79/EC).
The directives aim at ensuring a high level of protection of human health and
safety and proper functioning. The directives define safety and performance
requirements for medical devices sold in the EU and apply to both products
and manufacturers. They have been supplemented over time by several modi-
fying and implementing directives.
European legislation
on medical devices
EU Directive Device category Class/list NB involvement Dutch registration
European
registration
MDD
93/42/EC
Medical
device
class I X
NOTIS system
(CIBG/Farmatec)
Eudamed
class Is
√ to assess
“sterile” or
“measure” aspect
IGZ via NB
class Im
class IIa
√ IGZ via NBclass IIb
class III
IVDD
98/79/EC
High-risk IVD
list A
√ IGZ via NBlist B
self-tests
Low-risk IVD other X
NOTIS system
(CIBG/Farmatec)
AIMDD
90/385/EC
AIMD n/a √ IGZ via NB
Table 1 – Overview of medical devices directives, categories, classes and lists

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9. Certification and registration Medical devices on the European market22 ttopstart
About ttopstart
ttopstart is a science and business consulting company that serves leading research-
ers and innovative companies in the fields of life sciences and medical technology.
We acquire funding for cutting-edge research and development, co-create corporate
strategies and conduct detailed market assessments. Our driver is the contribution to
development of innovations that can strongly advance healthcare, such as diagnostics
and treatments for a wide range of diseases with unmet medical needs.
If you need more information or require advice on the regulative aspects of commercial-
isation of a (active implantable) medical device, in vitro diagnostic or medical software,
please contact us:
Contact and information
Contact us
info@ttopstart.com

10. Certification and registration Medical devices on the European market 23
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