(EU) 2023/607 – 26 May 2024 deadline approaching

[Contenuto in lingua inglese]

Manufacturers to put in place an MDR compliant QMS and formally apply to a Notified Body under MDR

On 20 March 2023, the Regulation (EU) 2023/607 amending the MDR and IVDR was published in the Official Journal of the European Union (OJEU) with immediate effect. The objective of the Amending Regulation is to address the projected imminent risks of shortages of medical devices in EU due to the slower than anticipated transition from the medical device Directives to MDR and IVDR.

The amending Regulation extended the MDR transition timelines while also recognising as valid previously issued MDD/AIMDD certificates for the duration of those extended transition timelines. This allowed manufacturers to continue placing their devices on the market based on compliance to the Directives while they continue the transition of their devices to the MDR. However, it is important to note that the longer transition timelines (up to the end of 2027/2028) apply only to devices that are transitioning to the MDR and meet other specific conditions set out in the Regulation. These conditions are aimed at ensuring that the manufacturer has taken steps to transition to the MDR.

A summary of the main points from the new Amending Regulation is outlined in the communication sent on the 20 March 2023.

According to Regulation (EU) 2023/607, in order to benefit from the extended transition timelines and continue placing legacy medical devices on the market, the manufacturer must meet specific conditions as per the amended article 120 of the MDR. Among these conditions, no later than 26 May 2024, the manufacturer shall put in place a quality management system in accordance with MDR Article 10(9) and the manufacturer or the authorised representative must lodge a formal application with a notified body for MDR conformity assessment.

Be aware that, at the time of application under MDR, certain QMS documents shall be provided as per the applicable Annex (e.g., Annex IX, Section 2.1) as well as a plan for Technical Documentation submission.

Manufacturers recommended to not postpone/delay their MDR plans

While additional time is now available for completing the MDR transition, BSI strongly recommends that manufacturers who have already made or planned their MDR applications and documentation submissions with BSI, do not deviate from their plans and to submit the MDR Technical Documentation promptly. Manufacturers can refer to the dashboard published by the European Commission on “Monitoring of availability of medical devices on the EU market” for determining the average certification timelines under the different conformity assessment routes. It is the manufacturer’s responsibility to submit their MDR Technical Documentation to the Notified Body allowing sufficient time to complete the conformity assessment activities considering the applicable transitional timelines and the average certification timelines.

Finally, BSI recommends that any pending MDR applications for legacy devices be submitted without any further delay as we are fast approaching the 26 May 2024 deadline.

Where can I find additional information?

You can visit our MDR dedicated webpage to access additional resources to support you, along with our MDR transition guidance and a FAQ document with answers to most frequently asked questions in relation to this Regulation and associated topics.

If you have additional questions, please contact us at medicaldevices@bsigroup.com

Our priority remains to maintain patient safety and ensure compliant conformity assessments for all products within the new regulatory framework.

Sincerely,

Maddalena Pinsi

Associate Head of Medical Devices Notified Body & Senior Regulatory Lead Regulatory Services, BSI