medicaldeviceslegal

The MDR amendment proposal: more than meets the eye

On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in the works for some time was finally published. As I have heard from many directions immediately after the announcement of the proposal being […]

medicaldeviceslegal

The MDCG cybersecurity guidance – a helpful rush job

It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]

medicaldeviceslegal

The MDCG MDR joint implementation plan

The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story. Not the IVDR This implementation plan is not about the IVDR, and the fact that it is not about the IVDR is information in itself. It means that the MDCG is not even […]

medicaldeviceslegal

Brexit is a fact – now deal with it

Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing […]

medicaldeviceslegal

A not so happy MDR and IVDR Christmas Carol

Just before the Christmas holidays the Commission updated its rolling plan and the MDCG ongoing guidance overview. As the year draws to an end, the date of application of the MDR is very close now and I see more and more things happen that everybody could see coming for a long time, I would like […]