Informational From RAPS – Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’

[Marcelo]

Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’

Posted at Marcelo's Medicaldevice.expert website...

You may comment and discuss in this discussion thread.

 

[Edward Reesor]

I remember participating on a US-based webinar regarding the EU MDR a few years ago. I can't recall the exact numbers, but it was stated that prior to this revision, there were 80 or so NB's. It quickly dropped to 64 the following November, was approximately 56 at the time of the webinar (July 2017) and was expected to decrease to 40 shortly thereafter. So this shouldn't come as a shock to anyone, especially to those creating these new rules.

Not unlike Canada's poorly executed mandatory MDSAP program, this will limit access to technology and potentially patient care. This is a clear example of creating a solution to a problem that didn't exist.

 

[Watchcat]

I beg to differ. Problems definitely existed. Many of the NBs that have already disappeared should probably have never been designated in the first place, and many that are still around are still little more than the second best of a poor field. There was a reason NBs that had virtually never withdrawn a certificate were suddenly falling all over themselves to withdraw them once they learned that they would have to be redesignated under MDR/IVDR.

The NBs that finally get redesignated...based on their performance under the MDD, one can only hope that they do better, although so far it's not clear to me how much the MDR/IVDR encourages improvement.

As for the execution of the MDR/IVDR, I've been looking forward to this grand regulatory drama for years now. Can't hardly wait to see how it all plays out. It's like one of those movies for which they shoot a number of alternative endings, and no one in the cast or crew knows which ending will ultimately win out.