On 19 June 2015, the Council under the Latvian presidency reached an agreement on a general approach for the medical devices and IVD regulations and cleared the way for trilogue negotiations between the Council, the Commission and the Parliament to work out a final text. The negotiations are likely to start in September of this year.
Partial general approach
Because of the controversy around some critical issues and the complexity and volume of the proposed legislation the general approach adopted is a "partial" general approach excluding the recitals. Before the trilogue discussions start the Luxemburg presidency (succeeding the Latvian presidency as per 1 July) will need to draft these recitals besides further work that will need to be undertaken to fill technical gaps and solve inconsistencies. As for the trilogue discussions, this may prove to be a difficult task given Member States' remaining concerns (cfr. infra). It is not unlikely that Member States will continue to fight the areas of concern before and during the trilogue discussions.
The Council's position and the main concerns
The Council's position is in many aspects similar to that of the Commission and the Parliament. However, some significant differences exist, notably in the following areas:
- Notified bodies: Changes proposed by the Council include a stricter designation process for notified bodies and increased supervision of such bodies by national competent authorities. From their side, notified bodies gain powers to conduct unannounced inspections.
- Post-marketing surveillance: The Council's proposed amendments require that the manufacturer (i) sets up a post-marketing surveillance system proportionate to the risk class and type of device, (ii) files periodic safety update reports on an annual basis and (iii) acts faster in case of public health threats or deaths caused by the device
- Clinical investigations for medical devices: the Council advocates a greater protection for patients in clinical investigations
- Clinical evidence: For high risk devices, manufacturers must provide the results of clinical investigations to demonstrate a positive benefit/risk ratio of their product. In this respect the Council proposes to allow manufacturers of class III products to take the advice of an expert panel in respect of their clinical investigation strategy.
Despite the agreement on the partial general approach, Member States at the time of the vote expressed concerns with respect to the proposed changes and 2 Member States, namely Germany and Poland voted against an agreement. Some of these concerns have been shared by industry throughout the legislative process: e.g. the scrutiny mechanism adding unnecessary burden to the procedure and delaying patient access, the reprocessing of single use devices not providing equal levels of patient safety, increased requirements for clinical evidence for IVDs without clear benefit to patients as well as the financial cost of the implementation of the legislation.
Provided the Council manages to finalise its work in time and trilogue negotiations can begin after the summer recess, an adoption of the new regulations can be expected by mid 2016 with implementation to follow by 2019.