On 27 November 2025, the EU published Commission Decision (EU) 2025/2371 in the EU Official Journal, declaring the first four modules of Eudamed (Actor, UDI/Device, Notified Bodies & Certificates and Market Surveillance) as functional. This marks the start of the different time periods before mandatory use of various elements that will start on 27 May…
Further information has emerged from the Commission regarding the timelines for mandatory use of the six EUDAMED modules, shifting the estimations from the July 2025 timeline chart, which now includes an “Under review” note. Further to the implementation of Regulation (EU) 2024/1860 regarding the gradual roll-out of the six EUDAMED modules and the November 2024…
The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has published the user fees applicable to submissions, etc for fiscal year 2025, running from 1 October 2025 to 30 September 2026. The new fees represent between a 10% and 20% increase over the 2025 fees. Further details are available from…
As part of its post-Brexit demarcation from the rest of Europe, the UK has introduced stand-alone Post-Market Surveillance (PMS) regulations that have been integrated into The Medical Devices Regulations 2002. The new requirements apply to Great Britain (GB), comprising England, Scotland and Wales. Northern Ireland will continue to recognise the EU regulations for medical devices,...
The International Medical Devices Regulators Forum (IMDRF) has issued guidance on when and how regulators should share information about the potential postmarket risks of certain medical devices. On 1 April, IMDRF’s National Competent Authority Report (NCAR) Exchange Program Working Group published guidance titled ‘Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and…
MedTech Europe, together with COCIR and other European industry associations, have published joint papers on two important topics for medical device manufacturers in the context of the forthcoming review of the Medical Device Regulation (MDR, 2017/745). The topics are: Recognition of MDSAP certificates for the purpose of CE marking, and Clinical strategy as part of…
Currently, electronic Instructions for Use (eIFUs) are only allowed for certain types of medical device, e.g.: If they are for professional use and use by other persons is not foreseeable: Implantable and active implantable devices, Fixed installed medical devices and their accessories, and Medical devices and their accessories fitted with a built-in system visually displaying…
MDCG 2019-6 has been revised and reissued as Rev.5, with changes related to ‘structured dialogue’ and ‘leveraging evidence’ being included. The main change has been to add section IV.13, ‘What is considered “Leveraging evidence”?’, which explains that: “notified bodies should avoid unnecessary duplication of work when performing their conformity assessment activities. In this respect, a…
The International Medical Device Regulators Forum (IMDRF) on has finalised two technical documents detailing guiding principles for good machine learning practices (GMLP) and risk characterization for medical device software. The final IMDRF GMLP document lists ten guiding principles for good machine learning practices. The principles include understanding the product’s intended use; implementing good software, design,…
For anyone in the medtech industry seeking up-to-date information relating to the performance of actors within the regulatory sector covering the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746), the on-line dashboard provided by the Austrian National Public Health Institute (Gesundheit Österreich GmbH/GÖG), in collaboration with Areté and Civic Consulting, commissioned…
