Category - MDR

medicaldeviceslegal

The notified body conundrum

In my recent post about potential mass extinction in the EU IVD market as a result of the IVDR and the limited number of notified bodies that look to be applying for IVDR status (and the incredulous reactions that I received) I though it would be a good idea to update on notified bodies in […]

medicaldeviceslegal

EU MDR / IVDR Regulatory Cassandra

Sometimes you have days that you feel like Cassandra. I had a Cassandra moment after moderating the MDR panel at the Advamed MedTech Conference on 25 September. Cassandra was a lady from mythological heritage. She made the Greek god Apollo angry by changing her mind to be his girlfriend after he had granted her the […]

medicaldeviceslegal

Final MDR and IVDR texts published

As Agent Smith said: “You hear that Mr. Anderson?… That is the sound of inevitability…”. Today’s EU Official Journal contains the final final final texts of the MDR (finally numbered as Regulation (EU) 2017/745) and the IVDR (finally numbered as Regulation (EU) 2017/746), downloadable in any language that you could possibly like. I wish you a pleasant […]

medicaldeviceslegal

MDR and IVDR to be published this Friday

Mark 5 May 2017 in your calendar – this date will be a landmark for EU medical devices law because the MDR and IVDR will be published in the EU Official Journal. This means that the MDR and IVDR will enter into force on the twentieth day following that of their publication and from that date […]

medicaldeviceslegal

This is it: MDR and IVDR texts now ready for final voting

The fat lady has her lines and is about to sing. After the lengthy legal linguist revision process (remember, these texts have to be consistent in 24 languages) the Council published the text for its first reading for the MDR and IVDR.   First reading only, after such a lengthy process in which we arrived at […]

medicaldeviceslegal

EU Court decides TÜV Rheinland / PIP breast implants case

It has been sort of hanging over the medical devices market for quite a long time: the TÜV Rheinland case about the PIP breast implants. This case is the direct result of the PIP breast implants scandal, which had a profound influence on the new EU MDR in the making. We had the Advocate General’s opinion […]