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:Â Link to Regulation
- Current version of the MDR:Â Link to MDR
- Q&A Document by the EU:Â Link to Q&A Document
Latest news
Implications of the Update to the Borderline & Classification Manual under MDR and IVDR
On 12 September 2025, the European Commission published Version 4 of the Manual on Borderline and Classification under Regulations (EU) 2017/745 and 2017/746, developed by the Borderline and Classification Working Group (BCWG).
Regulatory Affairs Bulletin: Intended Purpose vs Intended Use under MDR & IVDR
European regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) require precise definitions in technical documentation, and the distinction (or overlap) between intended purpose and intended use remains a topic of operational significance.
-250x250.jpg&w=256&q=75)
MedNet EC-REP GmbH at MEDICA 2025 – Visit Us in Hall 3, Booth D43
MedNet EC-REP GmbH is pleased to announce that we will once again be exhibiting at MEDICA 2025 in Düsseldorf, the world’s leading trade fair for the medical technology industry.
EU eIFU Regulation Update Draft: What Medical Device Professionals Need to Know
The European Commission has introduced a significant amendment to Implementing Regulation (EU) 2021/2226, impacting how medical device manufacturers provide instructions for use (IFU).
Understanding the Interplay: MDR, IVDR, and the AI Act – Key Insights from MDCG 2025-6
Recently, the MDCG, in conjunction with the Joint Artificial Intelligence Board (AIB), released the MDCG 2025-6 FAQ document, offering essential clarifications on the interplay between the MDR, the IVDR, and the Artificial Intelligence Act (AIA).
Navigating IVDR and MDR Performance Studies: Key Insights from MDCG 2025-5 Q&A
The European Medical Device Coordination Group (MDCG) has released its latest guidance, MDCG 2025-5, a comprehensive Questions & Answers document addressing performance studies for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR).
MDCG 2019-11 Rev.1: Important Changes for Medical Device Software Developers
In the dynamic world of medical device regulation, staying abreast of the latest guidance is paramount for manufacturers. The Medical Device Coordination Group (MDCG) has recently released a significant update to its MDCG 2019-11 guidance document, now designated as MDCG 2019-11 Rev.1.
MDCG 2025-4: Key Guidance for Medical Device Software on Online Platforms
The European Commission's Medical Device Coordination Group (MDCG) has released the MDCG 2025-4 guidance document, titled "Guidance on the safe making available of medical device software (MDSW) apps on online platforms."