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

Wearables – a seminar about legal and regulatory aspects

Wearables are getting more and more popular and start to move more into the healthcare field by tracking all kinds of data concerning physiological processes and performance. Some companies explicitly want their wearables to be medical devices, others prefer their wearables to stay out of that.  Some companies plan their data protection compliance for personal data […]

medicaldeviceslegal

Medical devices M&A – data protection

Lately I have been doing a lot of work in medical devices M&A projects, some very big, some quite small and some in between. Everybody seems to be merging with everybody else these days as the bigger companies divest branches to reposition and smaller companies put themselves up for sale. These projects are invariably highly […]

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 […]