BREAKING: EU agreement on new MDR and IVDR

After almost four years after the initial proposals the Dutch presidency has shepherded the proposals for the MDR and IVDR across the finish in the trilogue negotiations, as was announced just now today. This was a quite unexpected result as the first time we expected (or hoped) to hear about this was the EPSCO Council meeting next month. The current agreement has been reached in the trilogue negotiations and still has to be formally approved by the Council and Parliament ( Council’s Permanent Repr [...] « Read the rest of this article on medicaldeviceslegal »