Stay informed about the latest regulatory requirements, industry developments, and expert insights from MedNet EC-REP
EUDAMED Actor Registration is now mandatory for every manufacturer placing devices on the EU market. Here are the five mistakes we see most often during initial registration and how to avoid the delays they cause.
The MHRA has opened a consultation on fee increases from April 2027 — including a proposed 70 % rise in the post-market surveillance fee. Manufacturers have until 25 September to respond.
Do you need an EU Authorized Representative? Learn who needs one, their obligations, liability, and how they differ from importers and distributors.
Legacy and Regulation devices under transition must be registered in EUDAMED by 28 Nov. 2026. Learn who's affected, how EUDAMED-DI/ID registration works, and how to avoid mistakes.
The EU PPWR applies from 12 August 2026, no grace period. See the compliance steps medical device and IVD manufacturers need now. Read the guide.
New EU study finds 48% of manufacturers have withdrawn devices from the market.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.
Privacy Settings
We value your privacy. This website uses cookies to enhance your browsing experience and analyze site traffic. Please review and customize your privacy preferences. For more information, please see our Privacy Policy.