Deadline Alert: Submission Requirements for MDR Conformity Assessment

We're pleased to provide you with important updates regarding the extended transition period for certain medical devices under Regulation (EU) 2023/607. As the landscape of medical device regulations continues to evolve, it's crucial for stakeholders to remain informed and compliant.

In 2023, the European Union introduced Regulation (EU) 2023/607, which extends the transitional provisions for specific medical devices. This extension is accompanied by detailed conditions outlined in Articles 120(2) and (3) of the current version of the Medical Device Regulation (MDR). For a comprehensive understanding, we encourage you to consult the official documents linked below this article.

One of the critical conditions mandates the submission of a formal application for an MDR conformity assessment to the Notified Body by May 26, 2024 (as per Article120(3C (e)) of MDR). For those who have not yet taken action, we stress the urgency of meeting this deadline to ensure compliance.

• Regulation (EU) 2023/607: Link to Regulation
• Current version of the MDR: Link to MDR
• Q&A Document by the EU: Link to Q&A Document