When can mhealth apps be a medical device?
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1 When can mhealth apps be a medical device? E-HEALTH WEEK (AMSTERDAM, 9 JUNE 2016) Erik Hansson, Deputy Head of Unit, DG GROWTH - Health Technology and Cosmetics, European Commission
2 Outline software within the medical device regulatory framework in the EU 1. Legal background 2. Revision of Medical Device legislation
3 1. Legal background Safety and performance requirements for software and apps falling under the definition of a medical device (MDs) or an in-vitro diagnostic medical device (IVDs) are regulated by the respective directives: Directive 93/42/EEC (MDs) Directive 98/79/EC (IVDs)
4 General principles: Apps that must fulfil the requirements of the medical devices legislation. - Apps intended to have a medical purpose action such as apps intended to: create or modify medical information for facilitating perception and/or interpretation display images using techniques alternating representation - Includes apps intended to support diagnosis and treatment of disease or injury such as transfer of body temperature, weight, pulse/oxygen or electrocardiogram info (sensor/implanted or manually entered data) if interactive by generating a message or alert or coach patient in medication and/or reports back to health care provider.
5 Outside the scope of the medical devices legislation - Apps providing passive information such as general static advice.
6 What happens if an app is a medical device? - It must comply with the safety and performance requirements set in Annex I to the Directives - Such compliance must be assessed through a specific conformity assessment procedure, which is proportional to the risk-class: For low-risk products (Class I), the manufacturer can provide a self-declaration For all other products (Classes IIa, IIb and III), a control must be done by a Notified Body - Other obligations for manufacturers regard the issues of registration, post-market surveillance, incident reporting.
7 Examples Medical device (Class IIa) app: a) App using signal data from an external source and processes it to an ECG waveform thereby performing an action on data other than storage. Not medical device: b) App allowing storing of data on each moment of contradiction during birth delivery with possibility to make notes and take pictures for future use: storage and simple search c) App showing illustrations of the anatomy of the human body and introduces anatomical terminology etc: not used for medical benefit of individual patients.
8 Borderline and classification issues A- "Guidelines on the qualification and classification of standalone software used in healthcare within the regulatory framework of medical devices" (MEDDEV 2.1/6, January 2012) - provides practical advice to determine when a software/app falls under the definition of a medical device or of an IVD medical device as well as its class. - update will be published in the summer. B- Manual on Borderline and Classification - provides a list of concrete qualification/classification examples for which consensus was achieved among Competent Authorities.
9 2. New proposals for Regulations on MDs and IVDs New Regulations on MDs and IVDs to replace the existing Directives. A political agreement on the two texts was reached at the tenth trilogue on 25 May Formal adoption is expected by the end of the year
10 Main issues discussed in the field of software/app New safety and performance requirements Regulatory impact of the location of software Regulatory status of software/app without a direct medical purpose Dedicated classification rules for software/apps
11 Useful links - MEDDEV Guidance 2.1/6 ents/1/translations/en/renditions/native - Manual on Borderline and Classification ents/1/translations/en/renditions/native
12 Thank you for your attention!
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