Last Friday (April 3rd), it became official. The European Commission will delay the validity date of the new Medical Device Regulation (EU MDR) by one year. The new implementation deadline is thus 26 May 2021, and the proposal for this has now also been published. One of the reasons for the delay is the COVID-19 crisis, which represents a huge challenge for public health. Member States, health authorities and economic operators should now prioritise the fight against coronavirus. In addition, there are currently just 12 MDR-certified Notified Bodies, which would make recertification considerably more difficult for many manufacturers.
MedTech market disruptions must be avoided
Stella Kyriakides, Commissioner for Health and Food Safety, said: “Our priority is to support Member States to address the coronavirus crisis and protect public health as powerfully as possible, by all means necessary. Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided. Today’s decision is a necessary measure in these very exceptional times.”
According to Peter Reinhardt, Chief Editor of Germany’s Devicemed, what we now need is a quick reconciliation between the European Commission and the parliament and the council to make this delay possible, and with that, also be able to extend the Medical Devices Directive (MDD).
The MDR moratorium most likely comes as a relief to many MedTech companies. As the results of our EU MDR Readiness Survey show, many medical device manufacturers were not yet prepared for the new requirements, and 77% assessed the regulation as “very difficult”. Nevertheless, this is not the time for complacency either. The coming year will pass quickly and we will likely face very similar challenges again in 2021 as we do today. Our survey results show that some have already made good progress in terms of MDR implementation. However, many still lag behind, especially in terms of clinical data collection as part of their Post-Market Surveillance (PMS). Systems that are based on paper or Excel sheets will simply not be able to keep up in the post-EU MDR era. For this reason, we advise all manufacturers not to waste any time, but to use this as an opportunity to rethink their MDR strategy. Many issues can also be addressed independently of the COVID 19 crisis, such as choosing an automated, web-based clinical data capture solution. We would be happy to tell you more about this in a free, personal software demo.