Upcoming Deadline for MDR Conformity Assessment Agreements 

As the September 26, 2024, deadline for MDR Conformity Assessment Agreements rapidly approaches, medical device manufacturers are reminded of the crucial need to secure signed agreements with Notified Bodies to comply with the Medical Device Regulation (EU) 2017/745 (MDR) transition timelines.

Details of this deadline can be found here, on the EU commissions website.

This deadline is crucial for manufacturers looking to utilize the extended transitional periods, as per Regulation (EU) 2023/607, regarding the continuation of placing legacy devices, under the Medical Device Directive 93/42/EEC (MDD), on the market. 

To learn more about how you can streamline your medical device to the EU market, click here.

Key Requirements for Manufacturers 

To meet the upcoming deadline, manufacturers must ensure they have: 

1. A formal application lodged with their Notified Body: By 26 May 2024, manufacturers or their authorized representatives should have lodged formal applications with a Notified Body for MDR conformity assessment. In addition, the manufacturer should have received a formal acknowledgement letter of their application. 
2. A QMS that meets the requirements of the MDR: By 26 May 2024, manufacturers should have established, documented, and implemented a QMS compliant with Article 10(9) of the MDR. 
3. Signed Agreement(s) with a Notified Body: By 26 September 2024, manufacturers must have finalized signed agreements with their Notified Bodies. 

Common Pitfalls to Avoid 

Ensuring compliance with other transitional provisions: Manufacturers must also fulfill several conditions to take advantage of the extended timelines, including maintaining compliance with the MDD, avoiding significant changes to a device’s design and intended use, and ensure that the devices do not pose any unacceptable risks. 

The Clock is Ticking 

With less than a month remaining, manufacturers who have not yet secured agreements with Notified Bodies need to act immediately. Keep in mind that Notified Bodies require adequate time to complete and process the application. Therefore, prioritizing following up with the Notified Bodies is critical to avoid non-compliance and potential market disruptions. 

Act Now to Ensure Compliance and Avoid Market Disruptions 

The approaching deadline of September 26, 2024, marks the last pivotal moment for manufacturers aiming to align with MDR requirements. Hence, meeting this deadline is essential to ensure compliance and secure the extended transitional timelines.  

If you have any questions or need further support, do not hesitate to reach out to MedEnvoy for any MDR consulting services or assistance with securing a Notified Body agreement, contact us so we can assist you. To learn more specifically about our EU service, click here.

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