Category - notified bodies

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

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

Festive alert! Change is on its way.

Change is on its way – medical devices law will not be the same again as of next year. Panic soccer The authorities are not your friend anymore. Notified bodies are engaging in massive ‘panic soccer’ (Dutch expression) dropping companies like they’re hot. If you have not implemented the new clinical evaluation MEDDEV fully by […]

medicaldeviceslegal

In the mean time: a Staff Working Document

It’s been somewhat quiet on this blog for some time, not only because I have been very busy with lots of interesting cases but mainly because there was not a lot going on in the medical devices regulatory developments field. Yes, market parties have been working on their input for the consultation about the Green Paper […]

medicaldeviceslegal

ENVI’s 29 may debate on medical devices

The fog of war that I wrote about with respect to the tsunami of amendments is lifting with the discussion of the amendments in the ENVI committee today. It was a very interesting debate, and I’ll share my impression of it with you. I have grouped what I heard by subjects so it’s easier to […]

medicaldeviceslegal

Fireworks! Or a disappointing dud? The 26 February ENVI workshop on the EU medical devices and IVD proposals

With the ENVI committee “workshop” on the medical devices regulation and IVD regulation proposals in sight next week, medical devices media have been drumming up momentum by using exciting adjectives like ”fireworks” that make this workshop sound like it will be an ‘epic battle‘, or how about a ‘clash of the titans’? I wouldn’t want to go […]

medicaldeviceslegal

“U” is for unannounced audits – what’s up with those?

I visited the RAPS Regulatory Convergence conference in Seattle, which provides for a very nice opportunity to catch up with the European medical devices crowd that had gathered in numbers to explain the current changes in EU medical devices law to the US audience and to each other. Apart from the ever charming and authoritative Ms […]