2 October 2026
Overview of the September 2026 news not already reported: MDR/IVDR Reform progress under new Presidency, IMDRF September meeting presentations, and more.
11 September 2026
MDCG 2020-16, the guidance on IVD classification, was updated to clarify the rationale and revise examples for Rule 7 under IVDR Annex VIII.
2 September 2026
August 2026 regulatory roundup covering EUDAMED updates, PPWR FAQ changes, new MHRA fee consultation, new IMDRF guidance on SaMD PCCPs, and more.
7 August 2026
Overview of the July 2026 news not already reported: new MDCG guidance clarifying who is responsible for UDI assignment, updated UK and Swiss guidance, and more.
20 July 2026
The European Commission has published an updated list of each Notified Body's (NB) price lists, which NBs are required to publish per the EU MDR/IVDR. Click here for the link.
2 July 2026
Overview of the June 2026 news not already reported: Change in SS(C)P process for manufacturers, Guidance on the Packaging and Packaging Waste regulation, and more.
22 June 2026
The EN ISO 15223-1 'Authorized Representative' symbol is officially changing from 'EC REP' to 'EU REP'. Here we outline the MDCG’s guidance on the transition period.
18 June 2026
Standards have been updated and newly harmonized under the EU MDR/IVDR, including a change that impacts labeling for non-EU based manufacturers. Click here for more.
2 June 2026
Overview of the May 2026 news not already reported: AI Act postponement, new EUDAMED functionality, proposal to amend the EU-Monaco Agreement, and more.