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.

Surveillance Transfer

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.

(MDR) (EU) 2017/745

Guidelines for MDR technical documentation submissions.

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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.

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Article 16(4) Certification Scheme requirements

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ISO 42001 - a commitment to ethical and responsible AI use

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Best practice for Submitting Periodic Safety Update Reports

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Annex XVI

Products without an intended medical purpose.

MDR Annex XVI regulates products without an intended medical purpose including devices used for aesthetic indications and dual use products. Thanks to our experience and expertise we are accepting Annex XVI applications since December 2022 and we have more than 60 ongoing applications to date. If you want to know more around Annex XVI and its regulatory framework or want to discover how BSI can walk you through your compliance journey, access our dedicated resources.

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