On May 22, 2014, the COREPER Working Party (which advises the Council of the European Union (EU) met to discuss the two proposed Regulations. As we reported here, on May 15, 2014, the proposed new EU Regulations on medical devices and in vitro diagnostic medical devices are moving steadily towards final adoption. The big story in the EU over the past several days has been the European Parliament (EP) elections (and the lead-up to them), but this has not impacted progress on the medical device legislation.
For now, it seems that broadly, the medical device legislation is proceeding as planned, with no significant issues being raised. The Greek representation to the EU is very keen to ensure that the regulations will work properly and, before the end of their term in June, Member State representatives within COREPER will reach agreement on the wording of the texts. Effective applicability, therefore, will be a key focus that will require detailed discussion on all aspects of the texts. Greece is a key player because it has the current Presidency of the EU until the end of June, and runs the Council and COREPER. COREPER is the designation of two working groups/committees of officials whose task is the preparation of meetings of the Council. COREPER is an acronym made up of the initial letters of the French title for the Committee of Permanent Representatives, Comité des Représentants Permanents. COREPER comprises the Permanent Representatives of the Member States (i.e., ambassadors to the EU) and their deputies.
Although discussion has finished on most parts, COREPER is nevertheless a few steps from finalizing the entirety of the texts. The representatives will focus on the two Chapter 6s (clinical evaluation and clinical investigations/clinical evidence) during the next COREPER meetings, which will take place on June 3, 10, 13, and 25, 2014. Although most expect agreement, it will be more difficult to achieve consensus on the Chapter 6s than the other chapters.
On June 20, 2014, the relevant Member State ministers will meet (as the Council), with this legislation on the agenda. Most likely the June 25, 2014 COREPER meeting will be a "wrap-up", dedicated to passing on the file to the Italian Presidency, whose term starts on July, 1, 2014, and the new EP (for a second reading). The Greek Presidency hopes to be able to deliver a fully-worked and agreed position for both texts. This seems to be virtually certain, despite the work needed on Chapter 6.
As to the scope for lobbying at this late stage, COREPER appears to remain open to new position papers. The Regulations are not (completely) "done deals". A paper would, however, have to address something important and, to have any chance of moving the position, receive wide acceptance by the Member States. At this stage, a paper could be sent to the Greek Presidency, the other Permanent Representations (Member State representatives on COREPER) and, at a later stage, to the relevant EP Committees when the texts go back to the EP for a second reading. The Italian Presidency would also in due course have to be involved.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
