PRESS RELEASE FROM REGULATORY & QUALITY SOLUTIONS (R&Q)

R&Q Hosts Virtual Events for Medical Device Manufacturers

Posted Mar 31, 2020

Pittsburgh, PA: Due to the COVID-19 outbreak, all in-person events hosted by Regulatory & Quality Solutions (R&Q) have been rescheduled as virtual events. Most notably, our Strategic Solutions for EU MDR Workshop is now a virtual event being held on April 16, 2020. Learn more and register here.

Nancy Morrison, R&Q's Executive Director, Regulatory & Quality Consulting Services, shares her thoughts on the potential impact of the COVID-19 pandemic on the EU MDR timeline: The calls for delaying EU MDR in the midst of the COVID-19 public health emergency have come from multiple sources including Industry trade groups, Notified Bodies (NB) and Competent Authorities. 

The Commission announced Wednesday that they plan to initiate action to delay implementation by one year moving the date from May 26, 2020 to May 26, 2021. The intent to pursue a one-year delay has been published but is not yet an official change; in fact, it isn’t even drafted. Here is the audio recording of the question.

COVID-19 is further reducing the European Union competent authorities’ ability to conduct the necessary activities to designate additional NBs. COVID-19 effects of travel restrictions, reduced workforce, and the widespread stay at home orders have enormously compounded an already challenging endeavor for the competent authorities to designate more NBs in a timely manner. As a result, a heavy workload concentrated to a small number of NBs leaves many manufacturers with undesignated NBs at a loss for a path and the necessary guidance to MDR certification.

Current NBs certainly have the capability to conduct some audit activities remotely, but there are portions of the conformity assessment process, such as verifying manufacturing processes, that must be done at the physical manufacturing facility. There is a requirement of some amount of on-site work that is required prior to issuing CE certificates and due to social distancing measures being put in place across the globe, it is difficult to know when these necessary audits will resume.

As always, we continue to regularly provide a variety of virtual resources available to you at any time at RQTeam.com.

About R&Q: Regulatory & Quality Solutions (R&Q) improves people's lives. We accelerate the success of medical device, IVD, and combination product companies by providing industry-leading regulatory and quality consulting solutions. Our ISO 9001 certified quality system has processes designed to enable the performance of any service remotely. Whether you require a combination of onsite experts and remote support, or 100% remote support, R&Q delivers industry-leading services.

Source: Schlemmer, F. Team-NB. Team-NB stat[e]ment on Covid 19. Published 12 March 2020. Accessed 19 March 2020. https://www.team-nb.org/publication-of-a-statement-on-covid-19/