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.
MedNet EC-REP
Author
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
Related Articles
New EU Study: Where Manufacturers and Authorised Representatives Really Stand on MDR and IVDR
New EU study finds 48% of manufacturers have withdrawn devices from the market. Key MDR/IVDR and AR findings for 2026. Read the numbers now.
Well-Established Technologies Under the MDR: EU Commission Expands Exemption List
The EU Commission has expanded the WET list under the MDR, easing requirements for certain class II and class III devices.
MHRA Device Registration: New Clarification on "Placing on the Market" and "Putting into Service" (Update 20 July 2026)
MHRA clarifies medical device registration: 20 July 2026 update explains "placing on the market" vs. "putting into service" in GB.
Stay Updated
Get the latest regulatory updates and industry insights delivered to your inbox.
Subscribe to Updates