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…
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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…
MHRA call for evidence on designated standards for medical devices and IVDs
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a call for evidence to collect feedback from stakeholders on the use of designated standards…
MedTech Europe on simplification of EU digital legislation and State of the Union Address
MedTech Europe recently published two position papers on the latest development on strength, resilience, and competitiveness policies in the medical technology sector. With the first…
Call for evidence on the targeted revision of EU MDR & IVDR
On 8 September 2025, the European Commission launched a Call for Evidence on the targeted revision of the EU rules for medical devices (MDR) and…
EUDAMED: timeline as of August 2025
This summer, the European Commission was expected to announce the functionality of five EUDAMED modules. With this announcement, Actor, UDI/Devices, notified body/certificates as well as…
Switzerland aligns with the EU on new eIFUs regulation
In August 2025, Swissmedic announced to adopt the new EU requirements on eIFUs with immediate effect. With this alignment, it is possible to use electronic…
Swissdamed device registration module is now available
In August 2025, Swissmedic announced the new UDI Devices module in Swissdamed is live. The registration is voluntary and will become mandatory only in July…
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