Important Update on EU Medical Device Regulation (EU MDR)

Great news for medical device manufacturers! The EU MDR extension period offers some additional time for placing certain devices on the market. Here are the key details:

For MDD certified Class III devices and Class IIb implantables, the market placement deadline has been extended until 31st December 2027.

For Class IIb, IIa, and I devices, the new deadline for market placement is 31st December 2028.

However, please note that devices can only be placed on the market during this extended period if all the following conditions are satisfied by 26^th May 2024:

• Manufacturers must have a Quality Management System in place, complying with Article 10(9) of the EU MDR.
• Manufacturers or their authorized representatives must have lodged a formal application for conformity assessment, as per section 4.3, first subparagraph, of Annex VII.

By 26th September 2024

• The notified body and the manufacturer must have a signed written agreement in accordance with section 4.3, first subparagraph, of Annex VII for conformity assessment.

It’s important to act promptly and ensure you meet these requirements to take advantage of the extended placement period. This extension provides valuable breathing room, especially for those who are still in the process of securing a notified body.

For more detailed information, refer to the relevant MDCG documents on the EUDAMED platform. Stay compliant and seize this opportunity!

The rules and regulations explained in this article are based on Regulation (EU) 2023/607 of the European Parliament. For more details : https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf