The US Food and Drug Administration (FDA) has published the final version of its guidance document titled ‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’, superseding the draft published in June 2018.
As in the draft, the guidance provides advice to medical device manufacturers on the following types of …
The International Standardisation Organisation (ISO) has now published a revised version of this cornerstone standard for biological evaluation of medical devices, which has been completely reorganized to align with the ISO 14971 on risk management for medical devices. The new standard, ISO 10993-1:2025, ‘Biological evaluation of medical devices – Part 1: Requirements and general principles…
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…
