EU Regulatory Roundup, May 2023: MDR Extension Updates Resume

May saw a resurgence of EU MDR news, following a few quieter weeks. Guidance on demonstrating compliance with extended transition periods and compiling clinical investigation reports were among the top-read articles in Medtech Insight in the past month.

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With the dust finally beginning to settle after the European Commission’s rush earlier in the year to rapidly adopt amendments to the Medical Device Regulation that extend compliance deadlines for some legacy devices, May saw a number of updates on the finer details of these new rules.

The EU updated its guidance document, MDCG 2020-3, which relates to “significant changes” for devices CE marked under the Medical Devices Directive or Active Implantable Medical Devices Directive regarding...

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