EPSCO Council discussions on the Medical Devices Regulation
On the 20 June 2014, the European Council’s Employment and Social Policy Council (EPSCO) discussed the status of the Medical Devices Regulation. The focus of the debate, which took place during the meeting focused on three pervading questions;
1. Does chapter IV of the proposals as amended by the presidency constitute a good basis for the further discussion on the provisions regarding designation and monitoring of notified bodies?
2. Are specific provisions on post-market surveillance under the responsibility of economic operators a necessary element to secure an adequate level of protection of patients?
3. Bearing in mind the aims of the proposed regulations, and in view of the resources required, is it desirable to allocate further tasks to the medical devices coordination group in addition to those foreseen in the Commission proposal?
Judging from the discussions during the EPSCO Council meeting it seems as though the debate on the suitability of pre and post market surveillance has definitely tilted more towards stronger pre-market surveillance through reinforced notified bodies and a post-market surveillance system that places the burden on the manufacturers more than any other economic operator.
Concerning the foreseeable timings for the conclusion of discussions within the Council, it is apparent that there is no urgent call for rapid progress on the dossier. This was clearly confirmed with some Member States: UK, Slovenia, and Spain calling for the dossier to be adopted at the end of the Italian Presidency and others such as Germany calling for careful and pragmatic examination of the text.
Please find the note on the EPSCO Council conclusions here