The devil is in the details: a deep dive into the state of Notified Body designations


While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations. While designation numbers are up, there are still concerns that manufacturers need to be aware of.

Though the European medical device and diagnostics regulations came into force seven years ago, regulators haven’t yet achieved the same number of designated Notified Bodies (NBs) as under the previous medical device and IVD directives.

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