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Standards: Explosion and Challenges Maintaining/Updating
My conversation with Subhi Saadeh of Combinate Podcast was very intriguing and he does a fun podcast. Check out the Combinate podcast #132 as I, Leo Eisner, talk about Standards.
Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.
DATELINE 27 MAY 2021: Wow! Some companies made it just across the line in time and I’m sure some didn’t. Did you? Not everyone agress with my perspective. Let’s get on with the story.
What does that all mean?
The MDD and AIMDD are dead (Dead on Arrival) and the MDR Date of Application (DoA) has just flown by us, yesterday. So, we are past the transition period, per say, for the MDR and now we’re into a grace (grey zone) for the legacy MDD/AIMDD products that can’t have any significant changes under their existing MDD/AIMDD certificates otherwise they need to go “full up” into MDR-land.
COMMISSION IMPLEMENTATION DECISION M/575 was issued 14 April 2021: This is a list of standards the EU Commission is hoping to Harmonize under MDR and IVDR. One of the issues is the HAS consultant has issued a negative assessment on
EU Commission promised 20 Designations 12 Notified Bodies Designated to MDR (9) & IVDR (3*) *All 3 IVDR Notified Bodies have MDR designation as well, so that can be counted as double counting. It depends on your perspective. 2 NB’s