Category - Recast

medicaldeviceslegal

A wave of MDR and IVDR rollout coming our way

With the clock for the countdown to the end of transitional periods for the MDR and IVDR ticking away, everyone is of course very interested what the competent authorities are doing regarding implementation of the MDR and IVDR, since a lot needs to happen to implement the MDR and IVDR. The Dutch competent authority gave […]

medicaldeviceslegal

MDR and IVDR workshop at Advamed on 4 December

At Advamed’s San Jose MedTech Conference this year it was quite a surprise for me to see how many US companies are still not doing what is necessary to become compliant with the MDR and the IVDR in time. In the EU MDR session at that conference about 5% of the audience raised their hand […]

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

IVDR, IVDs and mass extinction

More interesting things from the RAPS Convergence conference. If you do anything in the IVD sector in Europe and did not attend that conference, that’s a pity. The program on EU IVD regulation was truly outstanding. I do not often see such a good program on EU IVD regulation in one place – if you […]

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 […]