Boston, August, 2023 We’ve been gone for a bit – as in three years. Did we miss anything? Or, more to the point, is there anything that didn’t change?
Well, there was that whole pandemic thing. Amazing that despite the EU MDR and IVDR both written in 2017, and both supposed to be well into transition with adequate numbers of designated Notified Bodies and medical device manufacturers with CE Marked devices reviewed and approved under the new regulations, that still is a bit of a work in progress. And the MDCG has been hard at work with guidances galore, peaking at a record 21 in 2022 – but only 3 so far in 2023. Still, MDCG couldn’t fix or clarify the EU “Elephant In the Room” – which resulted in the EU issuing amended Regulation 2023/607 – an attempt to extend the validity of EC Certificates issued under the Medical Device Directives that were valid on the MDR date of application (26 May 2021) and have not been withdrawn by a Notified Body. For how long? That was attempted to be addressed in “Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 – Extension of the MDR transitional period and removal of the “Sell Off” periods. For a complimentary copy of the longest titled guidance In EU history, click here.
Then, there’s the FDA’s recently updated approach to regulating the exponential growth of SaMD vs. wellness apps. This is all explained in the latest guidance which interestingly enough is no longer perfectly aligned with IEC 62304. For a complimentary copy of the guidance, click here.
If you’re interested in discussing your medical device which was CE Marked under the MDD or IVDD, with or without a valid EC Certificate with a CRO Group consultant to review if it is subject to the updated MDR transition policy, and/or to prepare for MDR or IVDR Notified Body oversight, or if you’re developing or have developed a mobile app or other digital health product and would like to review how CRO Group may be of assistance in meeting the new FDA guidance, click here.