The EU Medical Device Coordination Group (MDCG) has released several new guidance documents in recent weeks, including: MDCG 2025-7 Rev. 1: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles MDCG 2025-8: Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle…
Donawa Lifescience President, Maria E. Donawa, M.D., has authored a ‘Regulatory Recap’ article on LinkedIn titled ‘Proposed MDR Amendments and Clinical Data Requirements.’ Following Dr. Donawa’s February 2025 LinkedIn article on the current MDR’s clinical data requirements, the Commission’s December 2025 proposed MDR amendments have now been reviewed with particular attention to clinical data and…
On 16 December 2025, the EU Commission published its ‘Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the…
The EU Medical Device Coordination Group (MDCG) has now published its long-awaited ‘Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746‘, MDCG 2025-9. The document explains that “In certain circumstances, a medical device (MD) or in vitro diagnostic medical device (IVD) may be described as a breakthrough device (BtX) when it represents an innovation…
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…
