Category - Eudamed

medicaldeviceslegal

A not so happy MDR and IVDR Christmas Carol

Just before the Christmas holidays the Commission updated its rolling plan and the MDCG ongoing guidance overview. As the year draws to an end, the date of application of the MDR is very close now and I see more and more things happen that everybody could see coming for a long time, I would like […]

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The Commission and the Council on the MDR state of affairs

The public part of the Employment, Social Policy, Health and Consumer Affairs Council meeting on last Monday, 9 December 2019 gave an interesting peek into how the Commission and the Council see the state of affairs with the MDR and IVDR implementation at the moment, and notably as well the delay of Eudamed implementation. The […]

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Eudamed delayed, but MDR not delayed – now what?

You may have already heard it from many directions: Eudamed is delayed with two years. Time to party now because you can shelve your MDR implementation project for two years and go back to do other things? Nope, unfortunately most probably not – read on. After some pretty mysterious statements of Commission officials in public […]

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What to expect for 2019 with MDR and IVDR implementation?

Remember the CAMD Roadmap (dating back to end 2017) that promised us a roll-out of MDR and IVDR items that were sometimes even marked ‘high priority’ and how that lifted our spirits (at the time)? Remember how this was supplemented with the Rolling Plan, which promised the roll-out of all roll-outs for 2019? I have […]