All medical devices entering the EU market have to pass the conformity assessment procedure and bear the CE mark. Earlier, essential requirements as well as the conformity assessment procedure were described in the Directive 90/385/EEC for active implantable medical devices and the Directive 93/42/EEC for medical devices.

To ensure better protection of public health and patient safety the EU Commission established Regulation (EU) 2017/745 on medical devices (MDR) on April 5, 2017. The MDR repeals Council Directives 90/385/EEC and 93/42/EEC and should be effective from May 26, 2020. However, the situation with COVID-19 in the world made the EU Commission to postpone the effectiveness of the MDR for one year.

The new MDR contains a 13-page introduction, followed by 123 articles in 10 chapters, and 17 annexes. The MDR promotes mostly a life-cycle approach to medical device regulation. That is why this Regulation applies to clinical investigations concerning medical devices for human use and accessories for such devices placed on the EU market.

The MDR came into force from May 26, 2021.

Please, note that devices that were legally placed on the market before the effective date can be sold for up to five years after the MDR takes effect, but their certificates will be terminated on May 25, 2024.‍

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The information has been prepared by the GMA Consult Group team. ‍

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