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Updates on proposed EU Medical Device Regulations - June 2016


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What will a company need to do if they already produce over 100 IVD products for the last 20 years? Will they need to provide clinical performance studies to update their IVD files with the EU?


At a recent ABHI meeting, it was stated that the implementation of the new MDR would take at least 18 months. Notified Bodies have to be redesignated which will take around 6 months then lots of other stuff to do.

I wonder if some of the smaller NBs will lose their accreditation when the MDR is imposed upon them?
I wonder if some of the smaller NBs will lose their accreditation when the MDR is imposed upon them?
I think this is almost certain, there has already been a degree of consolidation amongst NBs, plus the denotification of a significant number; this will only increase as the burden and oversight increases

The question for me is whether the NBs that aren't up to it are going to back out gracefully, in a manner that is supportive of their customers.

Julie O

Does anyone happen to have an old list of NBs, circa 2010-2013? I would be interested in tracing the impact of the new regulations/recertification on the NB landscape.


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OBL / OEM / Private labeling / Virtual manufacturer.

Just a few words used in relation to each other. In the end, none are defined in MDD/AIMD/IVDD or MDR/IVDR.

The MDR/IVDR are most clear, MDR: look into Article 10. That's what you need to have. And next, look into Article 51 to classify your device. Depending on the classification, look into Article 52 for the conformity assessment to be followed.

This means that anybody (natural or legal person) placing a device on the market needs to be able to demonstrate all these elements (and more...).

Only if you can do that, you are manufacturer.
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