COVID-19 Impact on EU MDR: UPDATE

by Madison Green | Apr 20, 2020 | Coronavirus, COVID-19, EU, EU MDR, FDA, Medical Devices, Quality Systems, Requirements

In our last blog on COVID-19’s impact on the EU MDR, the commission had not yet laid out any intentions of moving the EU MDR deadline, which was slated for next month. With close to 2 million confirmed cases globally, it seems that the pandemic’s impact has finally forced the commission to postpone the deadline for the EU MDR.¹On April 3^rd, the commission officially adopted a proposal to postpone the deadline by one year, meaning medical device manufacturers now have until May 26, 2021 to transition to the new regulation.

According to the Commission, the decision was not reached lightly. The transition deadline that was set for next month was something medical device manufacturers have worked tirelessly towards since the EU MDR was announced; however, the obvious need to prioritize the fight against COVID-19 has forced the postponement. It was recognized that the relaxation of the deadline would ensure that medical device firms could effectively address the worldwide shortage of critical medical devices. The coronavirus pandemic presents unprecedented challenges to all medical device manufacturers, and the commission recognized that postponing the deadline would allow firms to allocate the proper resources to the current public health emergency.

The Vice President for Promoting our European Way of Life, Margaritis Schinas, said “Shortages or delays in getting key medical devices certified and on the market are not an option right now. The Commission is, therefore, taking a pragmatic approach and delaying the entry into application of new EU rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic.”²The current EU directives for medical devices (including implantable devices) will stay in regulation until the new 2021 EU MDR date. The date for the IVDR, however, is still on target for May 26, 2022.

EMMA International is keeping up to date with all regulatory responses to the COVID-19 pandemic; give us a call at 248-987-4497 or email info@emmainternational.com for more information!

¹WHO (April 2020) Coronavirus Disease 2019 (COVID-19) Situation Report 85 retrieved on 04/15/2020 from: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200415-sitrep-86-covid-19.pdf?sfvrsn=c615ea20_4

²European Commission (April 2020) Commission postpones application of the medical devices regulation to prioritize the fight against coronavirus retrieved on 04/14/2020 from: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_589

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.