LAST CHANCE?

Angelina Hakim

Quality Management and Regulatory Affairs Expert|Owner & CEO QUNIQUE Group bei QUNIQUE GmbH

发布日期: 2020年3月15日

With less than 50 working days remaining until the date of application of the EU Medical Device Regulation (EU) 2017/745, medical devices manufacturers, notified bodies and competent authorities should be focused on completing their last preparations and getting ready for the 26th of May.

Since the outbreak of the Corona Virus, the focus has changed!

Many manufacturers are fighting for their existence amidst lack of supply and lack of orders, because most hospitals are either busy with Corona patients or preparing for the next weeks when the corona wave is going to hit their area.

With only 11 MDR accredited notified bodies and very limited resources, notified bodies are struggling to keep up with the new customer applications, revieweing the technical documentation of their old customers and performing the time consuming MDSAP and MDR audits. It is also worth mentioning that the travel restrictions to many countries accross the globe are making certification audits almost impossible. It is still not clear how many MDR certification audits had to be postponed due to travel restrictions but the number will be significant.

Even before the outbreak of the COVID-19, the European Commission was not very much on track with implementation of the MDR. With no EUDAMED in sight, lack of accredited notified bodies, BREXIT Chaos with the UK, unclear Mutual Recognition Agreement (MRA) situation with Switzerland, and lack of common specifications and guidance documents, just to name a few challenges the EC is facing in the implementation of the EU Medical Device Regulation.

Based on all the above, wouldn’t this be the best chance for the European Commission to reconsider its implementation plan and start with postponing the Date of Application of the MDR without losing face infront of the whole community? What are your thoughts?

Ary SAAMAN

Principal Consultant - Medical Devices and Combination Products

4 年

Indeed, as an “exceptional measure” let’s add two more years to the DoA and make it May 26, 2022. First of all, this will take the pressure off the current so-called Plans. It will also give enough time to resolve additional complicating issues like Brexit, Swixit, and Turxit. And it may be expected that the “corona-crisis” will have become a thing of the past by then. For now, all stakeholders would be able to focus on assuring continuity in the supply of medical devices (both for regular healthcare as well as those specific to deal with the corona outbreak) as well as assuring the continuity of their businesses: the corona-measures taken will have a profound negative impact on the European and world economy and it will take some time (years) to recover from that. It would also avoid that country specific measures would have to be taken on a case-by-case basis by the National Competent Authorities, who currently are facing more important challenges.?