French “Pilot phase” for the clinical investigation on medical devices
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In light of the upcoming entry into force of the EU Medical Devices Regulation ((EU) 2017/745) on 26 May 2020, France is the first EU country to prepare for its application in practice by means of a pilot project. The Regulation, amongst other things, sets out a revised framework for Ethics Committees and competent authorities for the clinical investigation of medical devices.
On 4 July 2019, the French National Agency for Medicines and Health Products Safety (ANSM) introduced a pilot programme for the clinical investigation of medical devices aimed at preparing actors for the upcoming organisational EU framework and identifying solutions. In particular, the pilot addresses the deadlines for file review, as well as co-ordination between the ANSM and the Ethics Committees.
The scope of the pilot phase includes initial authorisations for investigations of class III devices, implantable devices and class IIa or IIb invasive devices in all therapeutic areas. The project applies to (voluntary) academic and industrial sponsors and seeks to make them more familiar with the new procedures and thus to facilitate the application process for clinical investigation authorisations.
The pilot phase is expected to be launched on 16 September 2019.
On 19 July 2019, the ANSM also released guidelines for medical devices manufacturers, setting out recommendations which aim to help prevent cyber security attacks and shared them with the European Commission. It is the first time that such recommendations have been elaborated at EU level.
As noted by the ANSM, while the EU Regulations have been modified to accompany technological developments, they do not address the issue of cyber security, defined by the ANSM as:
"the full set of technical or organisational measures set up to ensure the integrity and availability of a medical device and the confidentiality of the information held on or output by this medical device against the risk of targeted attacks".
Moreover, to minimise the risk of attacks against medical devices and prevent data compromise, the ANSM asks medical devices manufacturers to undertake risk assessments using IT and medical devices risk management methodology.
The guidelines are subject to a public consultation until 30 September 2019.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, July 2019 Issue (Thomson Reuters).