EU Initiative on Medical Devices and In-Vitro Diagnostics: A Targeted Evaluation
The European Commission has launched a public consultation as part of its targeted evaluation of the EU rules on medical devices and in-vitro diagnostics. This initiative is focused on assessing the effectiveness, efficiency, relevance, and coherence of the current regulations. It aims to ensure that the regulatory framework continues to support innovation, public health, and safety in the rapidly evolving medical technology sector.
As a authorized representative for medical device and IVD manufacturers, MedNet EC-REP GmbH is committed to keeping stakeholders informed on these key regulatory developments. We encourage manufacturers, industry professionals, and other interested parties to engage with the consultation and share their views on how the regulations can be improved to meet future challenges.
The consultation is open for participation and we believe it offers an excellent opportunity for the industry to contribute to shaping the future of medical device and ivd regulation in the EU.
For more information on how to participate, please visit the official EU consultation page.
Latest news
MHRA Introduces New Device Registration Fee: What Manufacturers Need to Know
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its “DORS Fees Guidance 2.1”, introducing a new annual fee model for device registration.
EUDAMED’s first four modules become mandatory on 28 May 2026 - what this means for medical device manufacturers
The European Commission (EC) has formally declared that the first four modules of EUDAMED - the European Database on Medical Devices - will become mandatory as of 28 May 2026.
MedNet EC-REP GmbH to Exhibit at WHX 2026 in Dubai
MedNet EC-REP GmbH is excited to announce its participation in WHX 2026, taking place from February 9–12 in Dubai. As a trusted European Authorized Representative and compliance partner for global medical device manufacturers, we look forward to presenting our comprehensive regulatory services to an international audience.
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).