The European Commission simplifies the process for renewing notified body designations
The European Commission issued new regulations simplifying the process for renewing notified body designations prior to the postponed deadline for application of the Medical Devices Regulations (MDR), 26 May 2021.
Moreover, the Commission issued guidelines explaining the process and requirements for adopting EU-wide derogations for medical devices under MDR. In delaying MDR, EU authorities adopted provisions to allow for EU-wide derogations for medical devices prior to the full application of MDR as a means of addressing potential device shortages amid the pandemic.
Designation renewals
The European Commission said it will allow designating authorities to deviate from normal procedures to renew designations under the directives until MDR takes effect. This measure aims at coping with the big amount of notified bodies designations set to expire this year.
“Without valid designation, those notified bodies would no longer be able to issue certificates, and ensure their continuous validity,” the Commission writes, moreover it is “essential that notified bodies … are able to continue to operate until the new regulatory framework for medical devices under [MDR] becomes applicable.”
“This should allow designating authorities, in the context of the COVID-19 pandemic and the associated public health crisis, to derogate from the procedures … in order to guarantee the smooth and timely renewal of a designation before its expiry”
Those deviations are only allowed for renewing designations for notified bodies that have previously gone through the designation process and should be done before their designations expire.
For more details, please see Commission Implementing Regulation (EU) 2020/666.
EU-wide derogations
In its guideline on EU-wide derogations, the Commission explains the procedural and justification requirements for adopting EU-wide derogations and outlines the adoption process and other conditions for making such derogations.
The Commission stated that, to make an EU-wide derogation for a medical device at least one national derogation must be granted and notified to the Commission. Moreover, the justifications, parameters and technical documentation related to each derogation must be provided to the Commission and all other Member States.
In addition, the Commission may impose stricter rules for devices subject to EU-wide derogations than those established by a national derogation and it may consider additional information including comments submitted by Member States or the Medical Device Coordination Group in deciding to adopt an EU-wide derogation.
For more details, please see Communication on EU-wide derogations.
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Table of Contents
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A Practical RBQM Framework for Medical Device Trials
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EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
