Recommendation for a book about the EU regulations

Hi,

I am looking for a recommendation for a book about the EU regulations i.e. a book that gives an overview of the medical device regulations in the EU etc. Would anyone have some suggestions?

AL.

 

Old thread but unanswered. Regulations changes too often and what is in print becomes obsolete too fast, hence no books. If there was one, I would not rely on it. To get a baseline overview you would need to gather documentations per market (local country) and EU. There might be local differences in some aspects and sometimes people forget that Norway, UK, Switzerland are outside EU.

Secondly you would need to monitor changes and upcoming changes per local market and EU. On top of that I strongly recommend that you also monitor what experts writes about the regulations, it is not completely black / white after all...

 

RAPS has good (and reasonably up to date books) covering EU MDR. worth checking out.