EU MDD Designation Renewals for Notified Bodies

by | Jun 5, 2020 | Coronavirus, COVID-19, EU, EU MDR, FDA, Medical Devices, Quality Systems, Requirements

In light of the COVID-19 pandemic, the EU commission adopted the Regulation (EU) 2020/561 that deferred the application of the EU Medical Device Regulations, which were set to go into effect in May 2020 by a year. This also means that notified bodies which were designated to conduct conformity assessments for EU MDD can continue to do so until May 25, 2021.

However, for the notified bodies who have already been designated under the EU MDR; their designation under the EU directives is set to expire between May 2020 and May 2021. Without a valid designation, such notified bodies won’t be able to conduct conformity assessments and issue certificates for medical devices and their makers. The deferral of the application of Regulations and the deferral of the repeal of Directives make it necessary to renew the designations of such notified bodies.

Realizing the importance of keeping the licenses of the notified bodies active to avoid the shortages of important medical devices, on May 19,2020 the EU commission amended the  Regulation (EU) No 920/2013 that sets forth the procedures and the rules surrounding the renewal of notified body licenses under the directives. This amendment allows for designating authority to renew the licenses without having to comply with the procedures set forth in Article 3 such as conducting on site surveillance audits and expediting the renewals of their licenses.1

These amendments are only applicable to the renewals of the already designated notified bodies and will stay in effect only until the date of repeal of the EU Directives is declared. The designating authority will still carry out an assessment of the notified body in order to verify its continuous competence and will include review of documents and activities. The Designating authorities are also required to notify NANDO (New Approach Notified and Designated Organizations) if any renewals have been granted under this amendment.1

In conclusion, all of the notified bodies that were designated under the EU MDD, and have their MDD licenses set to expire soon, will not have to worry about their expiration, and medical device makers who need to renew their MDD certificates can continue to use their current notified bodies.

Have any questions? Call us at 248-987-4497 or email us at info@emmainternational.com.


1EU Commission (May 2020) COMMISSION IMPLEMENTING REGULATION (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies retrieved on 06/03/2020 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0666&from=en

 

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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