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.

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.

*Please note, for the MDR timeline, these changes can be considered effective only once published on the Official Journal.

Download the MDR timeline
MDR best practice guidelines

MDR best practice guidelines

Download our MDR Best Practices Guidelines to help you prepare and structure your Technical Documentation when planning your application to BSI for a conformity assessment of a medical device under the MDR.

Download the guidelines

What you need to know about the latest MDR

The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), had a transition period of three years. Manufacturers had the duration of the transition period to update their Technical Documentation and processes to meet the new requirements.

This long awaited text brings with it more scrutiny of Technical Documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations.

See the latest information on the EU website >

MDR resources to support you

Why choose BSI for your CE marking approval?

BSI The Netherlands is a leading EU Notified Body; we review Technical Documentation as part of a conformity assessment to ensure that medical devices meet the necessary safety and performance requirements to allow them to be placed on the market.

The BSI team has a unique set of expertise from our product and regulatory experience that allows us to provide a rigorous review of your Technical Documentation. This gives confidence in your certification to you and your key stakeholders.

BSI offers Technical Documentation review; you will be assigned a dedicated Scheme Manager to work with you throughout your product certification journey and will remain your point of contact thereafter.

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Software as a medical device

A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation

jmdr articleUnderstanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.

Hear from BSI’s Richard Holborow, Head of Clinical Compliance in his recent article in the Journal of Medical Device Regulation on the requirements for clinical evaluation under the MDR from a Notified Body’s perspective and how to meet those requirements.

Download the article
Dedicated training courses

Dedicated training courses

At BSI we offer training courses tailored to the Medical Device Regulation to help support and grow your business.

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