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Regulatory Services

Medical Device Regulation (MDR)

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.

To access legacy devices’ extended timelines, by May 2024 manufacturers must have implemented an MDR compliant QMS and have applied to a Notified Body for a Conformity Assessment.

By September 2024, the Notified Body and the manufacturer must have signed a formal written agreement. Depending on legacy devices classification, MDR transition deadline is May 2026 for Class III custom-made implantable devices, December 2027 for Class III and Class IIb implantable devices (non-WET) and December 2028 for other Class IIb, Class IIa, Class Is and class Im devices. On the same date, up-classified legacy devices (whose Declaration of Conformity was signed by 26 May 2021) now requiring Notified Body involvement must be MDR certified.

All legacy devices must be MDR compliant by the end of December 2028.

The sell-off period for medical devices already placed on the market under MDD and AIMDD has been removed. These devices can be made further available on the market without legal time restrictions.

For detailed information and conditions of applicability of transitional provisions, please refer to the Regulation amending (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices published in March 2023.

Key changes of the MDR

The major areas of change in the MDR include:

  • Technical Documentation.

  • Requirements for clinical evaluation and post-market clinical follow-up.

  • Increased traceability of devices (UDI).

European Union

Medical Device Regulation (MDR) 2017/745

BSI the Netherlands is a leading Notified Body (2797) achieving full-scope designation under MDR. We are also a full-scope UK Approved Body (0086) assessing medical devices against UK legislation. We review your medical device to ensure conformity against the relevant Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your device to the market.

For more information visit our CE marking and UKCA marking dedicated webpages.

Needed

Time for your MDR application is now

By 26 May 2024 you have to put in place an MDR compliant QMS and lodge a formal application with a Notified Body for MDR Conformity Assessment.

According to Amending Regulation (EU) 2023/607, if you are transitioning to the MDR, you will be able to benefit from extended validity of your directive certificates for legacy devices if some conditions are met.

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Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.

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