A New Phase Dawning in MDR Transition – The Sun Is Up!

Gert W. Bos, PhD, Fraps "I have a deep interest in the industry and a desire to make a difference in patient's lives by improving patient care. Even those who don't work directly with patients can still significantly impact patient care by developing safer devices and systems for the future. Safety measures and clinical performance should be equally strong and valid in all cases."

The last few weeks have made it clear to me that we are entering a new phase of the MDR transition. Three months after the stratified extension of timelines, and a clear deadline for application submission a year from now, we see that many MDR projects are moving into the next more decisive phase. Debates about final choices of which products will move into the application, and which ones will be phasing out, are taking place every day now. The pressure is on to get those key applications in.

Companies that were still waiting on their Notified Body to be designated are nearing the difficult moment to decide to shift to another Notified Body for the MDR application if they have not done so already. Luckily, we saw a few new MDR designations over the last few weeks. Also, there we see progress.

What we also see is that many are moving their attention to change control, and to getting additional approvals from their Notified Bodies on critical changes. As the extension will keep products much longer under the strict regime of limited or no change under article 120 from the MDR, companies cannot wait any longer with some critical production changes. In some cases, these changes are also needed to prepare for the products to be MDR application ready.  Luckily the Notified Bodies have some time at hand, as the shift in transition deadlines has also caused delays in some manufacturer’s projects, be it for the first submission, or for rebuttals of rounds of questions. Of course, not only the delay, but also wider processes of project halts, company restructuring etc. due to among others the high inflation rates seen over the last year.

That extra availability of Notified Body resources will also support the newly positioned structured dialogues, allow manufacturers and Notified Bodies to spend time to clarify processes, details and logistics of submissions, reviews, and audits. Ultimately supporting continued market access of critical products for the support of patient healthcare.

The new dawn also brings a revised energy in guidance. Critical guidance on clinical evaluations, and further support and stimuli from the core-MD project will help all to get a more detailed understanding of key requirements. The big wait however will be for the product specific guidance that in the distant future might reach us in common specifications. Something to look for at the far end of our regulatory horizon. It will be clear that for the upcoming rounds of submissions the coming few years these common specifications will not play a huge role. But some elements of central feedback can be utilized. As reviews from the expert panels are reaching the public domain, general lessons learned from them can be applied across the board for all king of products, with class III products and further implants benefitting most from the additional expectations surfacing.

The sooner you get in line, the better. As in time the Notified Body capacity will get absorbed into recertifications, change review requests for both legacy products and already MDR certified products, and more.

With the summer upon us, it is time to briefly reset, and after some rest get in motion to enter into the new phase! Get the applications prepared, focus on change control, and get ready for the upcoming MDR audits! Wishing you an enjoyable start of the next phase!





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