News & Infos
Stay informed and ahead in the rapidly evolving world of medical devices and regulatory affairs. Our News & Infos section is your trusted source for the latest developments, regulatory updates, and industry trends impacting the medical device sector across Europe and beyond. Whether you are a manufacturer, regulatory professional, or stakeholder in the healthcare industry, we provide timely, relevant information to help you navigate the complex landscape of compliance, innovation, and market access.
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.
EUDAMED Workshop: Essential Training for Medical Device Stakeholders
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.
Swissmedic Highlights Post-Market Surveillance Obligations for Legacy Devices
Swissmedic has released findings from a recent focused action, underscoring the critical importance of robust Post-Market Surveillance (PMS) for all medical devices.
EU Publishes Second Revision of MDCG 2023-3: Key Updates for Manufacturers
The European Commission has released the second revision of the MDCG 2023-3 guidance document in January 2025. This update includes important clarifications in line with Regulation (EU) 2024/1860
EU Commission Updates Guidance on SARS-CoV-2 Test Classification
The In Vitro Diagnostic (IVD) expert panel of the European Commission has released new scientific advice regarding SARS-CoV-2.
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.