Meet us at MEDICA 2025! ๐Ÿ“… Nov. 17โ€“20 | Hall 3 Booth D43 | Schedule a meeting

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

Implications of the Update to the Borderline & Classification Manual under MDR and IVDR

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

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.

MedNet EC-REP GmbH at MEDICA 2025 โ€“ Visit Us in Hall 3, Booth D43

MedNet EC-REP GmbH at MEDICA 2025 โ€“ 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 Dรผsseldorf, the worldโ€™s leading trade fair for the medical technology industry.

EU eIFU Regulation Update Draft: What Medical Device Professionals Need to Know

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 โ€“ Key Insights from MDCG 2025-6

Understanding the Interplay: MDR, IVDR, and the AI Act โ€“ 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

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

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

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."