DOES YOUR APP NEED CE MARKING?

Sofie van der Meulenwww.axonadvocaten.nl 24 juli 2013 Health 2.0 Amsterdam

Overview

• CE marking under the Medical Devices Directive: when is an app a medical device?

• What if your app is a medical device?

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:

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)

Software = medical device?

• MEDDEV 2.1/6

• Criterium

• Medical purpose

AND

• Diagnostic

And/or

• therapeutic functionality

Software = medical device?

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?

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

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)

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)

Medical device – Class I

Medical device – Class IIa

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.

Thank you for your attention

Sofie van der MeulenAxon AdvocatenPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500F +31 88 650 6555M +31 6 53 44 0567E sofie.vandermeulen@axonadvocaten.nl Read this blog:

http://medicaldeviceslegal.com