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
New MIR Form 7.3.1: Key Update for Incident Reporting under EU MDR
The European Commission has released a new version of the Manufacturer Incident Report (MIR) form which will become mandatory for all medical device manufacturers from November 2025.
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The European Commission is hosting a free, hybrid EUDAMED workshop in Stuttgart on May 21, 2025, designed to support the onboarding of all actors involved with the European Database on Medical Devices (EUDAMED).
EU Expands Harmonised Standards for MDR: Focus on Medical Gloves, Sterilisation, and Patient Transport Equipment
The European Commission has taken a significant step in strengthening the regulatory framework for medical devices by harmonising additional standards under the MDR.
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MedNet EC-REP at CMEF Shanghai 2025
We are pleased to announce that we will be exhibiting at the China International Medical Equipment Fair (CMEF) in Shanghai from April 8 to April 11, 2025.
New Revision of MDCG 2020-16 Guidance on IVD Classification: Key Updates in Version 4
The Medical Device Coordination Group (MDCG) has released Revision 4 of the "Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746" (MDCG 2020-16).
UK Updates Post-Market Surveillance Requirements for Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance on post-market surveillance (PMS) requirements for medical devices in Great Britain.
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ISO 15223-1 Amendment: EC-REP Symbol Changes to EU-REP
The International Organization for Standardization (ISO) has recently amended ISO 15223-1:2021, introducing a change from "EC-REP" to "EU-REP" for the European Authorized Representative symbol.
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MedNet EC-REP at MedTec Japan 2025 – Meet Us at Booth 3303
We are pleased to announce our participation as an exhibitor at MedTec Japan 2025, one of Asia’s leading trade shows for medical device design and manufacturing. The event will take place in Tokyo from April 9–11, 2025.