Category - Recast

medicaldeviceslegal

Medical devices and the #Brexit

Wow, while I was still working on wrapping my head around the hundreds of pages of final texts of the MDR and IVDR, the Brexit happened. Speaking of surprises – this was a big one. I do not want to use this blog for political statements, so I won’t bore you with my personal opinion […]

medicaldeviceslegal

Counting down to the final text of MDR and IVDR; more on software

It’s the final countdown! Following the trilogue’s agreement on the MDR and IVDR texts the Commission (DG Growth) confirmed at the eHealth Week in Amsterdam last Friday that (probably late) this Wednesday the agreed text of the MDR (and, I assume, IVDR too) will be made public as the signatures required will finally have been […]

medicaldeviceslegal

MDR and IVDR presentation

There was a lot of demand for the presentation referenced in my previous blog about the MDR and IVDR texts having been agreed because a lot of picture quality was lost in the document embedded in the blog. Thanks very much for all the interest and great feedback! White Papers and presentation Also the PDF version that […]

medicaldeviceslegal

BREAKING: EU agreement on new MDR and IVDR

After almost four years after the initial proposals the Dutch presidency has shepherded the proposals for the MDR and IVDR across the finish in the trilogue negotiations, as was announced just now today. This was a quite unexpected result as the first time we expected (or hoped) to hear about this was the EPSCO Council meeting next […]

medicaldeviceslegal

Product liability for devices under MDR and IVDR

With the MDR and IVDR nearing completion in the trilogue negotiations the final outline of these two statutes become more and more clear. It looks now like the regulations will be agreed upon during this Presidency, which means they could be published in the Official Journal and enter into force this autumn. I’m referring to […]

medicaldeviceslegal

New white paper on MDR (and where is the MDR anyway?)

When Gert Bos and I wrote BSI’s white paper on the impending EU medical devices regulation and the IVD regulation, the white paper was received very well but we also received requests to write something more detailed and practical. Here it is So we did just that. And here it is – the next BSI […]

medicaldeviceslegal

End of year bonanza

Normally one looks back at the end of the year, but I also like to look ahead because there are a lot of developments in EU law that will affect the medical devices industry next year: new rules on cybersecurity, data protection, mHealth and business compliance will put their mark on 2016, additional to the never-ending […]

medicaldeviceslegal

Trilogue MDR/IVDR will probably not complete this year

With the end of the political year in Brussels in sight I though it would be a good idea to give you an update on process (if you can call it that) in the trilogue for the MDR and IVDR. Work on implementation by delegated and implementing acts Let’s start with the good news:  a […]

medicaldeviceslegal

Update on MDR/IVDR trilogue

The trilogue has been quietly progressing, with a view to being concluded for this Presidency at the EPSCO meeting of the Council on 8 December after a final trilogue meeting planned on 3 December. That is, for this Presidency (the Luxemburg one). If the  Commission, Parliament and Commission do not manage to reach consensus on everything, the […]