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Preparing for an uncertain MDR deadline – keeping your focus during COVID-19 lockdown

So, hope you’re well and safe, and are slowly adjusting to working remotely from your lockdown situation. It is great to see how many virtual tools are available to support, and I can see our consultants using a few dozen tools to support everyone using their company chosen platforms.

Earlier this week we hosted two webinars to accommodate for the extreme numbers of delegates that could not fit into the virtual room. Erik Vollebregt and Bassil Akra were helpful in joining also the replay for a live debate in the Q&A section, as the upcoming delay of MDR brought a lot of questions on its potential impact.

Potential delay DoA of MDR

Obviously, we have to be realistic that this is currently a plan, but seeing political parties in Brussels immediately respond to the news with detailed views, the item must have been discussed. So hopefully we will see the Brussels pressure cooking at it fastest speed developing clear instructions and expectations. First responses appear to be that notified bodies will have more time to finish ongoing reviews that needed to be finished before the Date of Application, such as significant changes, early renewals, scope extensions, etc. Good news for some. The second benefit will be that manufacturers can continue to provide products to the EU market, that would otherwise be obsoleted; and in a time of crisis, supply of hospital equipment and consumables should continue as smooth as possible. PMS and PMCF plans that have been initiated should of course continue as scheduled!

The downside is that manufacturers are relaxing, and pressure on many MDR projects is released. A pity, as we might not see an overall delay of the grace period. Hence it would be best to continue projects as scheduled!

Brexit, Swixit, Turksit, and stopping Notified Bodies

Many questions in the webinar focused on the uncertainties caused by jurisdictions related to EU that accepted CE marking before. We appear to be moving to a hard Brexit, Erik indicated. But unclear at this stage is if the current crisis will shift the Brexit grace period. Also unclear if the extension of MDD and AIMD will be mirrored in the UK legislation. Swiss MRA and Turkish AKA agreements will not be finished by DoA, but if that timeline shifts, negotiations may continue. Yet it is prudent to make preparations in case they would fail. SO get an authorised representative if you are based in either country, change representative if your currently is located in one of these countries, and get some kind of representation in place in case you wish to continue your sales in Switzerland and Turkey.

Clearly also still confusion on Notified bodies that will stop operation. Old MDD certificates may move into the grace period, but they need to be monitored by the old NB tht issued them. Meanwhile you can start MDR application with a new NB, so you would have two NBs in parallel, one for the old certificate, and one for the new MDR one.

COVID exemptions

Of course in this time of first responses, many questions were raised on special exemptions to supply masks, kits and more from outside EU for immediate support. This is currently dealt with on national level, so each country has their own outbreak management processes. The commission is increasing coordination, such as with the recommendation to share nationally approved PPE masks etc.

Of course the usual in house production option identified in the national laws will remain in place as well.

EUDAMED

Eudamed already was delayed, and questions on alternative registration can be found on the website of the EU Commission at a dedicated EUDAMED section. And indeed, distributors do not need to be registered in EUDAMED, but the tracability should be one step up and down for all parties in the distribution chain; and all distributors should follow the specific requirements in MDR posed to them in article 14.

Guidances

Quite a few questions on where to find the latest guidances published by the EU commission, as it is cumbersome to all the time check for updates. Luckily the commission thought of that, and they have a listing of all newly published and updated documents. You will find it here in the DocsRoom!

Training

As we all move to safety in our lockdowns, audits and training are shifting to virtual as well. Some are replacements, others will be new such as best practices in remote auditing to name one. Check out our virtual offering here.

For support, check out our regulatory, quality and clinical services that historically have largely been available through virtual cooperation!

Keep safe!!


Gert W. Bos, PhD, Fraps
Post date: March 27, 2020
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