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The European Commission published two Implementing Decisions: EU 2022/6 and (EU) 2022/15 for the MDR (EU) 2017/745 and IVDR (EU) 2017/746on 5 January 2022 and 7 January 2022 amending Implementing Decision (EU) 2021/1182 and (EU) 2021/1195 all above references are
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.
In my last post on this Standardization Request I didn’t expect it to pass. I didn’t get into the politics that there was a possibility of pressure from various groups for this Standardization Request to be accepted even if not
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
Notified bodies can now do remote audits for the MDR and IVDR — Member states need to Notify the EU Commission of Notified Bodies not conducting on-site audits & the period of time this will not be happening. So remote