1. DOES YOUR APP
NEED CE MARKING?
Sofie van der Meulen
www.axonadvocaten.nl
24 juli 2013 Health 2.0 Amsterdam

2. Overview
• CE marking under the Medical Devices Directive: when is an app a
medical device?
• What if your app is a medical device?

3. Definition medical device MDD
‘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:

4. Definition medical device MDD
• 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 (art. 1.2a MDD)

5. Software = medical device?
• MEDDEV 2.1/6
• Criterium
• Medical purpose
AND
• Diagnostic
And/or
• therapeutic
functionality

6. Software = medical device?

7. Criteria
1. Is the software a computer program? (ISO/IEC 2382-1:1993)
2. Software incorporated in medical device or standalone-software?
3. Is the software performing an action on data different from
•storage, archival, lossless compression, communication or simple search?
4. Intended for the benefit of individual patients?
5. Diagnostic or therapeutic purpose?
6. Is the app an accesorry of a medical device?

8. Categories of medical software
1. Stand-alone software
• Qualifies as an ‘active medical device’ (Annex IX, section 1.4)
2. Accessory of a medical device
• Must be CE marked as an accesorry
3. Incorporated in a medical device
• Assessed according as part of the medical device in the regulatory
process
Other software is not covered by the MDD

9. Medical device - classification
Decision tree MEDDEV 2.4/1 rev. 9 (p. 21)
Rule 9 t/m 12 Annex IX MDD.
Does the app have a measurement function?
App intended for one of the following purposes?
-Supply or exchange energy;
-Control, monitor or influence the performance of a Class IIa, IIb or III
medical device;
-Supply or exchange energy, a medicine or other substance to or from the
body;
-Direct diagnoses or monitoring of vital physiological processes.
All other active devices are Class I medical devices (Rule 12 Annex IX)

10. All medical devices …
• Meet the Essential Requirements
mentioned in Annex I MDD
(substantiated through technical
file)
• Vigilance and Post Market
Surveillance
• CE marking
• Clinical evaluation (Annex I,
section I under 6a MDD)

11. Medical device – Class I

12. Medical device – Class IIa

13. CE marking – why comply?
Non compliant app = illegal
•Not allowed on the EU market
•Who wants to invest in illegal products?
•Product liability
In the Netherlands: active enforcement (fines) from 1 January 2014
announced by authority.

14. Thank you for your attention
Sofie van der Meulen
Axon Advocaten
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
F +31 88 650 6555
M +31 6 53 44 0567
E sofie.vandermeulen@axonadvocaten.nl
Read this blog:
http://medicaldeviceslegal.com