authorised representative

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The Council’s IVD regulation proposal for the general approach

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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Compromise texts for EU Council EPSCO meeting public

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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Surprise! More about unannounced audits

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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Netherlands medical devices compliance update

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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"E" is for economic operator – you know: the MAID

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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New MEDDEV on authorised representatives: everything you know is wrong

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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Regulatory considerations typically overlooked in medical devices M&A transactions

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…

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