#MedTechVoices 🗣️ continues with Vice President of Intelligence & Innovation, Jaishankar Kutty, who shares his thoughts on the EU MDR postponement.

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:

What's Next?

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 after 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, come 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 re-write instead of a Band-Aid approach?

In the meantime, the notified bodies will most likely pursue the following items:

Importantly, it will be imperative for manufacturers to conduct PMCF studies to gather further evidence to support all indications ahead of the new deadlines.

For non-Spotify users interested in the video version of this clip, you can view on the RQM+ LinkedIn page here.

For more thoughts and free resources from our industry-leading experts just like this, please check out the RQM+ Knowledge Center here.

Thank you for listening!