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And we are live! The MDR hurdle race is on!

Gert W. Bos, PhD, Fraps

For a long time, many of us have thought and lived the prospect of keeping the old MDD alive. But yesterday many joined the ‘bye bye MDD party’ to say goodbye to the old legislation that has served Europe so well for nearly 3 decades.

So, today is time to make up our minds. Party (and after-party) are over. We either have a headache, or we are filled with energy and vibes. I sincerely hope for the last, as there is quite a lot to do.

Today you should have the elements of PMS and PMCF in place. And have the economic operators registered in EUDAMED (although formally still voluntary, it is highly recommended to show your commitment to fulfil MDR requirements). And of course, there is the debate on what else is required, as debated in the blog I recently compiled with Erik Vollebregt.

Second thing to do is to ensure that today you will sign a new declaration of conformity for any class I product that will remain class I under the MDR. For those products, the entire MDR is applicable, as you can see in the guide recently published by the European Commission.

But there is more to do. If your current MDD notified body is not designated yet, you are in for a serious talk with them to understand their state of progress. Their likely date of designation. Likely date they can start the review and audit; likely date of certification. That rolling plan is critical in your choice to stay with them or find an alternative notified body.

And of course, for all cases, the sooner you have your QMS and technical documentation in place, the easier it will be. As with the practice of getting many MDD certificates extended until 2023 and 2024, many will join the crunch of trying to get an MDR certificate just in time. Current estimates from notified bodies however indicate that most companies will fail in securing a certificate in time using this strategy. It is therefore critical to not delay the process but push for rapid completion.

The service industry is also getting fuller and fuller. CRO’s, test houses, toxicologists, consultants, independent experts, they will ultimately start saying no, as they will be fully booked. SO when relying on them, start early. And with push now on PMCF, many require their CRO to support some of the work, not only for the MDR products, but also to keep legacy products on the market. Due to the new GSPR 10, toxicologists and biocomp/tox testhouses are filled with requests for new justifications, chemical rationals, chemical testing, and above all: repeats of biocomp testing as many relied on (very) old documents and too many deviations and justification from what today is considered best practice. Heard a notified body say recently they did in principle does not accept biocomp testing older than 2 years…

Benefit of the old MDD was that many were broad experts, and with all guidance and clarity it was feasible for people to be an all-rounder. Now under the MDR, getting it all in place requires cooperation between various experts. And that brings in the challenge of ensuring all parts individuals write and contribute to be aligned and consistent. And where cross functional teams we doable pre-pandemic, it appears our ability to adapt differs between companies: some found ways to collaborate more smoothly that ever, others are finding it hard to connect all staff working from home in an efficient manner. What is clear for all is that communication and alignment is more key that ever before.

Good news on the audit front. The number of deficiencies found in initial audits appear on average to go down. Lessons learned are happily shared by notified bodies, by consultants and by some early adapters alike. For dossier review to some extent also the numbers go down, partially because deficiencies are written more frequently on aggregate level.

Exciting times ahead of us. You can see it as a race; a race to win. But I would challenge you to see it as a company sport event day. Getting all to join, perform as good as they can, support each other, have fun, and ensure all reach the end before at the end of day the diner party starts!

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


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