Medical devices (MDs)
Order adapting French law to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
The main purpose of the Order is to:
- exclude from the general research regime research involving humans relating to MDs and introduce a section describing the new special provisions applicable to clinical investigations of MDs;
- incorporate the new definition of MDs;
- identify the competent national authorities responsible for MDs, as well as product groups which are not for medical purposes, as listed in Annex XVI;
- draw up the declarations to be made by the economic operators concerned to the National Agency for the Safety of Medicinal Products and Health Products (ANSM);
- delete the provisions which have become redundant with those of Regulation (EU) 2017/745;
- introduce the new vigilance rules;
- amend the provisions on criminal and financial sanctions, taking into account the new European texts.
Finally, since Regulation (EU) 2017/745 has its scope extended to include the product groups in Annex XVI, it is necessary to establish for each article of the Public Health Code relating to MDs whether the provisions of that article also concern those non-medical devices.