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Erik Vollebregt
I hope you won’t mind me doing a little bit of marketing for the non-devices activities of my firm. Axon Lawyers organises a seminar on cell-based therapies on 18 April in Amsterdam,…
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Erik Vollebregt
The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7….
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Erik Vollebregt
Just before last weekend the final e-labelling regulation was published in the Official Journal of the EU, see right here. As you will see when you run a compare (like I did)…
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Erik Vollebregt
This will be a very short post, because everything I could write down on the subject is in the interview I had with Ashley Yeo of Scrip Regulatory Affairs, that kindly consented…
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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
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…
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Erik Vollebregt
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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Erik Vollebregt
If there is one thing that I have learnt by now working with medical apps and medical device law is that physicians have little idea about rules for apps with medical functionality,…
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Erik Vollebregt
A recently published decision of the European Patent Office’s (EPO) Board of Appeal about European patents and clinical trials provides for interesting reading and for some important pointers about how to deal…