Stay informed about the latest regulatory requirements, industry developments, and expert insights from MedNet EC-REP
Three phases, one deadline: what manufacturers still need to check and submit before EUDAMED registration closes for devices already on the market.
Great Britain plans to drop the 2030 end date for CE marked MDR and IVDR devices. The UK Responsible Person remains mandatory.
MDCG 2020-16 Rev. 5 clarifies when IVD control material without an assigned value falls under class B, and when another rule applies.
From 16 to 19 November 2026, MedNet EC-REP will be at MEDICA in Düsseldorf – join us at Hall 17, Stand E05.
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New EU study finds 48% of manufacturers have withdrawn devices from the market.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.
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.