Medical Device Regulation (MDR)

Medical Device Regulation (MDR)

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MDR Medical Device Regulation
MDR Medical Device Regulation
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Medical Device Regulation

The European Medical Device Regulation (MDR) replaced the MDD and the AIMDD and entered into force on 25 May 2017 with 26 May 2021 as date of application. On 27 May 2022 MDD/AIMDD Annex IV certificates become void. By 26 May 2024 all manufacturers must comply with MDR requirements. On that date, all MDD and AIMDD certificates will be void. On 26 May 2025 MDD/AIMDD certified devices can no longer be made available on the market/put into service.


MDR documentation submission

Download our MDR Best Practices Guidelines to help you prepare and structure your Technical Documentation when planning your MDR Conformity Assessment application to BSI.


MDR conformity routes

Our guiding brochure will support you in understanding conformity assessment routes and in selecting the most suitable for your medical device.


Clinical Masterclass Series

Our webinar series is back!

Join us for part 2 of our Clinical Masterclass Series in 2023 and listen to our experts discuss various aspects of the MDR. From preparing a Clinical Evaluation Plan, to supporting you with preparing a Clinical Evaluation Report, advice on PMCF and SSCP and much more.

Training medical devices

Training courses

We offer training tailored to the Medical Device Regulation to help support and grow your business.