Author: Suzanne Broussard
The global COVID-19 pandemic prompted the 1-year extension of the Medical Device Regulation (MDR) 2017-745 date of application. The delay is creating a changing and challenging dynamic landscape for device manufacturers and notified bodies (NBs).
As the seriousness of the COVID-19 pandemic emerged in March, the European Commission recommended a 1-year extension to the MDR date of applicability, the Parliament and Council then acted quickly with an almost unanimous decision supporting the delay, and the extension was ultimately accepted by the member states and published in the Official Journal on 23 April 2020.
The ongoing pandemic has created a high demand for resources such as surgical masks, medical gloves, and other medical and personnel protective equipment — keep these supplies flowing is a top priority to protect both patients and healthcare workers. The delay of the MDR date of applicability was implemented to ensure that hospitals and healthcare facilities have a continued supply of devices during the critical times of the pandemic.
It is important moving forward to understand that the delay was not implemented to provide manufacturers with more time to become compliant with MDR, and the European Commission expects that manufactures are continuing to work to comply with the newest regulation. However, the delay presents both opportunities and challenges for manufacturers.
Of course, the biggest benefit of the delay is time. Time that is in short supply for manufacturers and NB dealing with the ongoing changes to device regulations. The extra time may most benefit manufacturers of class I devices that were short on time to take advantage of the grace period provided under the second corrigendum of MDR 2017/45. Manufacturers in the following positions have the most to gain by the 1-year delay.
The delay is also creating several challenges for both manufacturers and NBs.
Medtech Insight hosted an MDR discussion panel consisting of 3 outspoken and renowned experts on the regulations of medical devices in the European Union: Bassil Akra of QUNIQUE consultancy (formally of TÜV-SÜD notified body), Gert Bos of Qserve consultancy, and Erik Vollebregt of Axon Lawyers.1
The take home message from this highly respected panel was simple.
A year is not an extra year.
Several important considerations were raised in the panel discussion that device manufacturers should take into consideration.
The panelists agree there is much to do moving forward.
The additional challenges of social distancing and the general global lockdown brought on by the pandemic will impact the ability of NBs and manufacturers moving forward. A recent ruling allowing NBs to conduct virtual audits for MDD renewal was critical. However, delays will make the new extension seem like much less than a year.
1. EU MDR Panel Discussion: Why An Extra Year Is Not Really A Delay For The MDR – How To Survive Changing And Confusing Times. Medtech Insight https://medtech.pharmaintelligence.informa.com/MT142211/EU-MDR-Panel-Discus
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