medicaldeviceslegal

The MDR – where are we now?

There seem to be a lot of misunderstandings in the market about the current status of the MDR. Some think it’s finished (it’s not, at least not formally) and there is a lot of insecurity about when it will enter into force. Currently the MDR and IVDR are in the process of translation. The trilogue […]

medicaldeviceslegal

Software MEDDEV updated

The Commission issued an updated version of the MEDDEV 2.1/6 regarding standalone software on 15 July. After all the rumors around the difficult discussions surrounding the revision process I was very curious about the changes finally implemented. Unfortunately these changes turned out to be very limited and in my view do not change the scope […]

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 […]