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The summer of ’22 – the moment of hope and the moment of choices!

Gert W. Bos, PhD, Fraps
Finally, time to sit back and relax on the beach or go for some activities in the woods or mountains. Relax, enjoy family time, and restore your energy! But not for all, as behind the scenes a lot is cooking.

Plans are being made on how to overcome the challenges of not enough time, not enough resources in industry RA/QA, not enough notified body capacity, not enough lab capacity, expert panels, IVDR labs, etc, etc. The commission and MDCG are analysing the collected ideas that came in over the last few weeks from many stakeholders. Such measures when accepted will not structurally delay the transition into MDR and IVDR but will use all creative ways possible to free up the resources that are so needed to focus on the core job of transferring into the MDR.

That means looking into what every stakeholder can contribute. Manufacturers can ensure their submissions are timely, and as well-structured and organised as possible, including the answer rounds following the initial review. This means notified bodies can choose to close the major issues and defer the minor improvements till later, so they can follow up with the manufacturer after the issuance of the MDR/IVDR certificate. It might mean that guidance will be published with a transition period so that it does not become valid in the middle of an ongoing review. This means that potentially notified bodies could do more audits remotely. Notified bodies not to have to double audit for MDD and MDR. Designation of notified bodies to be for a longer period. Addition of scope for a notified body not to require a full-scale audit etc.

All of these and similar solutions contribute a little to solving the gaps. But alas, the gaps are bigger that this simple duct tape management will be able to handle. More might well be needed if we wish to keep the hospitals running at full speed.

Structural changes could be made to the transparency. Manufacturers to provide details on their timelines and which products will be phased out when, so hospitals and other health facilities can prepare for change. 

National Authorities could simplify the procedures for the market extension they currently apply under derogation (MDR article 59 / IVDR article 54) and non-compliant devices (MDR article 94b&97 / IVDR article 89b@92); they could have longer periods assigned to such exceptional approvals so renewal of such approvals is not necessary, and above all, the Member States could opt to accept each other’s reviews in these processes, so only one country reviews instead of all separately… 

Hopefully, these measures all together will not only be duct tape but will be able to generate some of the positives intended by the new regulations, so higher quality, more clinical evidence, and more transparency. That, after all, is the intention of the improvements, not just bureaucracy for the reason of bureaucracy…. But it means we will need to revert to trusting each other, working together, and being open and transparent. Many of the things we lost in the initial phases of a black and white transition. We need to look for the grey, and above all for the red, the caring for each other and especially for the patients. Only then will we be able to see the difference.

If we cannot or will not change behaviours within and between all stakeholders, it will be duct tape at best. And if that’s the case, only one thing will help, and that is a thing nobody really wants. Admit that we failed an organised transition and add a few more years to make it work.

Keep on breathing. Summer is there, so we all take a break. But take a short one, as there is a lot of work ahead of us!

Wishing you all a splendid summer break!

Qserve, your MedTech Partner for Regulatory, Quality Affairs and Clinical Trials

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