The new European regulations on medical devices was at the heart of the dinner-debate which was held on 21 January by the ACIDIM. It was an opportunity to list the questions that remain about the regulations which are expected to be adopted before this summer.
2016 is the year of the adoption of two new regulations on medical devices and in vitro diagnostic devices. An adoption that now has every chance of occurring before the summer is out.
This is the first information that appears from the back of dinner debate organised by ACIDIM (Executives Association of the European Industry Medical Devices) and led by its president Faraj Abdelnour.
Speakers at the dinner included Jean-Claude Ghislain, Deputy Director for Scientific Affairs and the European Strategy at ANSM, Mika Reinikainen, president of the RWRS (European Association of Authorised Representative) who was representing European agents, and Dario Pirovano, the consultant in charge of regulatory affairs with EUCOMED (European Federation of manufacturers and suppliers of medical technology).
Stakeholders helped establish a some progress, but the following areas are still under negotiation, predominantly between the Council and the European Parliament.
Some of the questions that remained were:
- the regulation of genetic tests
- the authorisation of the reprocessing of single use MD (very different positions between one member state and another)
- the liability insurance (mandatory or not manufacturers)
- the period of validity of certificates obtained with the directives currently in force,
- classification rules, including the incorporation of nanomaterials,
- regulating the use of certain products which have non-medical purposes,
- restructuring the EUDAMED database
- the experience level of those responsible for regulatory matters,
- harmonising the verification of medical devices which are high risk