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EPSCO Council meeting

Posted on 04.07.2019

MDR/IVDR’s status of implementation was on the agenda of the last Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) EU Health Ministers’ Council meeting in Luxembourg on 14 June (webcast available here). The topic had been tabled by Germany and Ireland who had sent a short briefing note to EU Member States in advance of the meeting (available here). Amongst others the note includes the request for an immediate analysis on EU Member States’ MDR state of preparedness and asks for further discussions between Member States, the European Commission and, if necessary, the European Parliament before the end of 2019.

At EPSCO while 20 countries expressed their concerns about the current state of MDR implementation readiness, calling e.g. for European solutions to overcome the issue of notified bodies’ availability and capacity, the European Commission restated its official position, i.e. the May 2020 deadline will be met.

MDR implementation has reached significant political attention and a majority of EU Member States sent a strong message to the European Commission that action of some kind is needed. MedTech Europe believes this to be a significant step forward.