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New EU study finds 48% of manufacturers have withdrawn devices from the market. Key MDR/IVDR and AR findings for 2026. Read the numbers now.
The EU Commission has expanded the WET list under the MDR, easing requirements for certain class II and class III devices.
MHRA clarifies medical device registration: 20 July 2026 update explains "placing on the market" vs. "putting into service" in GB.
In short: On 17 June 2026, the European Commission published the reference of EN ISO 15223-1:2021/A1:2025 in the Official Journal of the European Union (OJEU) for both the MDR and the IVDR. This amendment replaces the long-standing "EC REP" symbol with "EU REP" for the authorised representative in the European Union. The change is purely editorial, and you have a five-year transition period - until 17 June 2031 - during which both symbols remain valid.
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.