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Erik Vollebregt
As promised yesterday, here is a first impression of the IVD Regulation (IVDR) proposal that may lead to a general approach this Friday in the ESPCO Council. In this post I will…
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Erik Vollebregt
The two texts that will form the basis for the Council’s attempt to arrive at a general approach at the EPSCO Council meeting on 19 June that would allow it to start…
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Erik Vollebregt
If you’ve missed the 2014 RAPS conference you’ve missed out on the opportunity to learn a lot about unannounced audits by notified bodies. Not only were the notified bodies themselves out and…
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Erik Vollebregt
Last week I attended the Eucomed Compliance Committee meeting in Brussels, and presented on some of the compliance developments going on in the Netherlands with respect to medical devices. Just like all…
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Erik Vollebregt
In the series of articles on this blog discussing parts of the proposed EU medical devices and IVD regulations I am taking a look now at economic operators, or as Maurizio Suppo…
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Erik Vollebregt
Last week the Commission released a new MEDDEV guidance document on authorised representative as part of the package announced at the beginning of this year and this one is disruptive, especially if…
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Erik Vollebregt
It is a typical scenario: an M&A project is underway, gains momentum and before you know it the pressure is on. The deal must close in time! And then some regulatory points…