Earlier today, in the EPSCO meeting, all EU member states unanimously agreed to the proposal recommendations listed below. Belgium asked for a detailed root cause analyses of why the MDR roll out finds itself where it is today. Malta has asked for one single date as opposed to a staggered one based on classifications. There will be a legislative vote on this item in early 2023 with aspects of the MDR to be reviewed/amended by the 2027/2028 timeframe. The MDCG group will generate a new guidance document outlining the details of the postponement.
What We Know Now
In the interest of continued medical device availability and patient safety in the EU, France, Germany and Ireland proposed the following:
- Extension of the transition period to 2027 for Class III and IIb, and to 2028 for Class IIa and I
- Extension of validity of MDD and AIMDD certificates to suit the aforementioned
- Extensions only apply if:
- No safety signals from PMS data
- Notified body application for conformity assessment in place before May 2024 and/or
- QMS certified to MDR by May 2024
Prefer to hear Jai speak about this? Watch the short video above!
While we welcome the postponement, it does beg some questions. If this is done in the interest of patient safety and if the authorities are happy with the safety of devices currently out there and the regulatory mechanism by which they are out there ensuring patient safety, what’s the point of the MDR at all? Also, why the postponement to 2027/2028? Why not any later? What credible data validates the 2027/2028 timeframe? What ensures we won’t be in the same boat in 2027/2028? We’ve all heard rumblings about stifling innovation and preventing good products from getting to patients. How will the MDR prevent this unless there is a complete rewrite instead of a Band-Aid approach?
In the meantime, the notified bodies will most likely pursue the following items:
- Deploy a mechanism for MDD/AIMDD certificate extensions
- Technical file reviews per the sampling plan
- QMS audits per the typical audit cycle
- Unannounced audits will likely re-start/continue
- PMS reports to monitor any safety signals
- Continue ongoing MDR certification reviews