Category - Recast

medicaldeviceslegal

Bottlenecks, Brexit and stalling CAMD roll-out

With the summer holidays about to happen and the halfway point of the three year transitional period for the MDR on the horizon, let’s take stock of where we are. If you are a manufacturer and have just started thinking about this MDR or IVDR thing, you are in a bad place. Maybe you have […]

medicaldeviceslegal

Bottlenecks, Brexit and stalling CAMD roll-out

With the summer holidays about to happen and the halfway point of the three year transitional period for the MDR on the horizon, let’s take stock of where we are. If you are a manufacturer and have just started thinking about this MDR or IVDR thing, you are in a bad place. Maybe you have […]

medicaldeviceslegal

IVDR and MDR implementation seminar

If you are in the neighbourhood of Amsterdam this Wednesday 18 April, consider dropping by for our IVDR and MDR implementation seminar because there are still some seats left. IVDR is mentioned first here, because the seminar will focus on IVDs with our very special guest start Anja Wiersma who knows EU IVD regulations like […]

medicaldeviceslegal

Happy New Medical Devices Year!

Happy New Year everybody – may your transition to the MDR and IVDR be unproblematic and timely. May your management be convinced that making and selling medical devices is actually core business of the company and dedicate sufficient resources to your transition project. Halfway point of MDR transition 2018 is the year in which we will […]

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 […]