Marketing surveillance shaping up pre-Review with Dutch Minister feedback to Dalli Action Plan

Interesting developments after the joint plan for action that Commissioner Dalli sent to the member states in the beginning of February this year urging them to step up market surveillance in order to…


The new EU MEDDEV on stand-alone software as medical device

Some time ago I already gave you a look under the hood of it and now it is here, the new MEDDEV on stand alone software: an interesting document that provides a…


New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced

The EU just released its first MEDDEV of a number that were agreed upon in the recent MDEG meeting. More are expected to trickle onto the Commission’s devices web pages in the coming…

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