Brussels, 21/01/2016 (Agence Europe) - Inter-institutional negotiations to conclude a second reading agreement on medical and in vitro medical devices are being continued. The next inter-institutional trialogue (the first under the Dutch Presidency) will take place on 4 February.
The proposals for a regulation will define the marketing and follow-up of internally and externally used health products, following the adulterated breast implant scandal. These texts are based on 200 articles and 30 annexes (a total of 350 pages) and were presented three and a half years ago by the European Commission. Overall, they strengthen controls of these kinds of devices after they have been put on the market. They provide more powers and responsibilities for the notified bodies, these non-member public organisations or private companies appointed by the member states to authorise the commercialisation of devices that have the EC label. They also increase product traceability through a single identification mechanism for these devices.
So far, the European Parliament and Council have met five times since 13 October. They have discussed the scope of application for the regulations, the obligations incumbent on economic operators, product classification, traceability, clinical trials, data confidentiality, notified bodies, compliance assessment, market monitoring, cooperation between member states and control procedures for high risk mechanisms. The meeting on 4 February will be prepared by the Committee of Permanent Representatives to the European Union on 27 January and will be focusing on clinical trials. It may also look at questions of genetic councils and controls for high risk mechanisms, as well as points still pending. Two other meetings have already been planned by the Dutch Presidency on 25 February and 17 March. (Original version in French by Sophie Petitjean)