In November 2025, a new version of ISO 10993-1:2025 has been published. ISO 10993-1:2025 is the standard for the biological evaluation of medical devices, which…
EUDAMED functionality notice officially published
On 27 November 2025, the Official Journal of the EU released Commission Decision (EU) 2025/2371. With this announcement, ‘Actors’, ‘UDI and devices’, ‘Notified bodies and…
MedTech Europe on risk based approach PMCF
MedTech Europe has raised concerns to the European Commission and the MDCG about how the EU Medical Devices Regulation (MDR) post-market clinical follow-up (PMCF) requirements…
Latest industry position to simplify EU labelling requirements
In November 2025, MedTech, AESGP, COCIR and EUROMCONTACT released a joint position paper on digital label for Authorised Representative and Importer details. The European associations…
IVDR: 19 Notified Bodies on NANDO
On 21 October 2025, SGS FIMKO OY was added to the NANDO database as a notified body for the In Vitro Diagnostic Medical Devices Regulation…
Harmonised standards for surgical clothing and drapes, medical face masks and sterilizers
Today, 20 October 2025, the Official Journal of the EU released Commission Implementing Decision (EU) 2025/2078. This Decision amends Implementing Decision (EU) 2021/1182 to include…
Updated EUDAMED features: EAR to be notified of new Basic UDI
EUDAMED has recently introduced new features to their system. The database is regularly subject to improvements and updates. In the latest release, EUDAMED has several…
MedTech industry asks for empowerment of Europe’s innovation ecosystem
The European Commission opened recently a public consultation on the European Innovation Act. This imitative aims at addressing certain issues faced by companies in the…
MDR: 51 Notified Bodies on NANDO!
As of 7 October 2025, the NANDO database includes NOTICE as a notified body, which brings the total number of notified bodies under Regulation (EU)…
Master UDI-DI for spectacle frames and lenses
On 23 September 2025, the Official Journal of the EU published Commission Delegated Regulation (EU) 2025/1920. This Regulation amends Part C of Annex VI of…