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…
Donawa Lifescience congratulates PainChek Ltd on receiving United States (US) Food and Drug Administration (FDA) De Novo clearance for its PainChek® Adult Intelligent Pain Assessment App (DEN240073). This groundbreaking app is the world’s first smart device-based medical device for pain assessment, designed for individuals who are unable to reliably verbalize their pain….
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…
Donawa Lifescience provided a two-hour seminar to Chinese delegates on 28 October 2025 in conjunction with Leadvisor Global, a leading professional services platform. Donawa Lifescience had the privilege of delivering the first educational course under the Leadvisor banner: Course One – From China to the EU: Medical Device Regulations and Compliance Strategy, as part of…
This well-attended on-line Masterclass was a practical deep dive into how to successfully plan and launch pre-market clinical investigations in the EU under the MDR. Attendees discovered how to navigate country differences, identify the right investigators and sites, and streamline approvals for faster study starts. The speakers shared proven strategies to avoid costly delays and…
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…
The 9th EAAR Annual Conference on New Medical Device Regulations (RMD 2025) took place in Brussels, Belgium, on 24-25 February 2025, featuring speakers from across the MedTech industry, including regulators and notified bodies. Organized by the European Association of Authorised Representatives (EAAR), the conference serves as an inclusive platform for all stakeholders across the both…
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…
