10 May 2026
New Regulation 2026/977 establishes binding CE marking timelines, clock-stop limits, and cost transparency for MDR/IVDR Notified Bodies. Read more here.
4 May 2026
Find here an overview of the April news not already reported: Team-NB new and updated guidance, Article 10a decision flow chart, update on new common specifications, and more.
20 April 2026
MDCG 2021-24 has been updated. Rev.1 revises classification guidance across multiple rules including Rules 8, 9, 10, 12, 16, and 22 under the EU MDR. Click here to read more.
14 April 2026
The Commission is hosting web-streamed trainings all day on the following EUDAMED modules: Actor, UDI/Devices, Notified Body & Certificates. Click here for the dates and link.
7 April 2026
Three standards have been newly harmonized under the EU MDR. Click here for the update. Plus, a link to a consolidated list of all Harmonized Standards and Common Specifications.
3 April 2026
March EU, UK, and Swiss regulatory updates not already individually reported: MDR/IVDR reform progress, MIR Form 7.3.1 update, swissdamed manual entry delay, UK clinical investigation guidance, and more.
30 March 2026
MDCG Standards Working Group Feb 2026 updates: EC REP to EU REP symbol adoption and transition timing, and status of the ISO/IEC vs. EC court case.
20 March 2026
The EU Commission published two draft delegated acts, proposing to expand the MDR well-established technology list. Learn what devices are affected and next steps before formal adoption can occur.
3 March 2026
The IMDRF published its annual update to the Adverse Event Report (AER) terms, terminology, and codes. Click here for the link, and an overview of the new, modified, and retired terms.