EU MDCG 2025-9 Break Through Devices
The MDCG has issued the Breakthrough Device Guidance MDCG2025-9.
Ben KempDecember 22, 2025
Health Technology Assessment – 2026 Work Programme adopted
On Friday 28 November, the annual HTA Work Programme for 2026 was adopted by the Member State Coordination Group on Health Technology Assessment (HTACG). The Work Programme outlines the key activities and strategic priorities of the group for the upcoming year. The HTACG estimates that it will initiate around 50 joint clinical assessments (JCAs) of medicines with new active substances…
Ben KempDecember 11, 2025
The EUDAMED four first modules will be mandatory to use as from 28 May 2026
Dear Members, The European Commission published the update on the mandatory use of the first four modules of the EUDAMED database. A reminder that the modules are available for voluntary use, and members should look to input data well before the mandatory use date. The EUDAMED first four modules will be mandatory to use as from 28 May 2026 View…
Ben KempDecember 10, 2025
Team NB Position Paper on IVD changes to companion diagnostic devices
The position paper can be found here: TEAM NB Position Paper on IVDR Changes to companion diagnostic devices - team-nb
Ben KempNovember 13, 2025
NB Position Paper on significant change – V2 published
You can find the paper here.
Ben KempNovember 13, 2025
Health preparedness: EU reference laboratories improve disease surveillance data
Health preparedness: EU reference laboratories improve disease surveillance data On EU Lab Day, the European Commission marks one year of improved coordination on surveillance data thanks to the EU reference laboratories (EURLs). This is part of the Commission’s work to coordinate robust preparedness, early warning and response mechanisms for health crises, as part of a strong European Health Union. The…
Ben KempNovember 13, 2025
EU UDI and UDI EUDAMED module updates
📌 On 29 October 2025, a new meeting of the Subgroup on Unique Device Identification (UDI, WG 9) of the Medical Device Coordination Group (MDCG) takes place, in its sessions for Competent Authorities only, and with the Stakeholders also. 👉 The draft Agendas, working documents and subsequent minutes are going to be made publicly available on the "Register of Commission…
Ben KempOctober 31, 2025
Regulation (EU) 2025/2083 of the European Parliament and of the Council of 8 October 2025 amending Regulation (EU) 2023/956 as regards simplifying and strengthening the carbon border adjustment mechanism (Text with EEA relevance)
Dear members, please be advised that the EU have amended the Carbon Border Adjustment Mechanism legislation. This will impact imports into the EU for certain goods containing high CO2 materials. CELEX:32025R2083: Regulation (EU) 2025/2083 of the European Parliament and of the Council of 8 October 2025 amending Regulation (EU) 2023/956 as regards simplifying and strengthening the carbon border adjustment mechanism…
Ben KempOctober 22, 2025
EU Cybersecurity Regulation Correction
The legislation corrects a mistake in the EU Cybersecurity Regulation: CELEX:32024R2847R(04): Corrigendum to Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU)
Ben KempOctober 22, 2025