Category - notified bodies


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 […]


“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 […]