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European Union Postpones Medical Device Regulation


The European Commission adopted Regulation (EU) 2020/561 on April 23, 2020. This Regulation amends Regulation (EU) 2017/745 on medical devices and postponed the dates of its application.

Initially, the MDR was meant to come into force from May 26, 2020. The MDR is more comprehensive and detailed in comparison with the Medical Device Directives and contains 123 articles and 17 annexes that made some issues for the manufacturers of medical devices as well as for the notified bodies to meet the MDR requirements.

Currently, only a small number of notified bodies got accreditation against the MDR.

Сonsidering the current situation in the world with regards to COVID-19 outbreak and the need of vitally important medical devices for medical treatment, the European Commission adopted a proposal to postpone by one year the date of application of the Medical Devices Regulation. These actions will allow Member States, health organisations as well as business entities to fight against the coronavirus pandemic more effectively.

Thus, Directive 90/385/EEC and Directive 93/42/EEC are still valid and will be effective untill March 24, 2021.

Please note, certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 will remain valid until their date of expiry, which shall not exceed five years from its issuance. However, they must be cancelled at the latest on May 27, 2024.

The full text of the Regulation (EU) 2020/561 you can find via the link.

The information has been prepared by the GMA Consult Group team. GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side. Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.

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