Stay informed about the latest regulatory requirements, industry developments, and expert insights from MedNet EC-REP
From 1 July 2026, all medical devices placed on the Swiss market must be registered in the national swissdamed database. Together with this registration obligation, the Swiss Federal Council has approved a revised Swissmedic fee ordinance introducing a product registration fee. The first invoices will be issued in January 2027. Here is what to expect.
The EU expands the use of electronic Instructions for Use (eIFU) for professional-use medical devices under Implementing Regulation (EU) 2025/1234. Key compliance considerations for MDR and IVDR manufacturers.
The European Commission has adopted Commission Implementing Regulation (EU) 2026/977, introducing binding uniform rules on how notified bodies must handle quotations, conformity assessment timelines, and re-certification. For manufacturers of medical devices and in vitro diagnostic (IVD) medical devices, this regulation brings long-awaited predictability - and specific new compliance obligations.
Planning to sell cosmetics in Europe? Discover the essential compliance requirements and strategic tips that non-EU manufacturers need to successfully enter the EU market.
The European database for medical devices, EUDAMED, is entering a new phase. With several modules now declared fully functional, the use of the system - including the UDI/Device registration module - will soon become mandatory for economic operators under the EU MDR and IVDR.
MedNet EC-REP GmbH will be exhibiting at CMEF Shanghai 2026. Meet our regulatory experts and discover how we support your EU market entry.
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MedNet EC-REP is pleased to announce that we will be exhibiting at MedTech Japan 2026, one of Asia’s leading events for medical device innovation.
The MDCG released new PMS guidance in December 2025. Learn what MDCG 2025-10 means for your MDR and IVDR compliance strategy.
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 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.
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.
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. This bulletin clarifies the regulatory definitions, their implications, and guidance interpretations.