[2025-09-18] On September 18, 2025, the Post-Marketing Surveillance and Vigilance working group of the MDCG (Medical Device Coordination Group) posted a number of working documents on the European Commission‘s website relating to the “trend report”. These documents are part of the list of 7 documents (guidelines and other deliverables) planned
[2025-09-23] (Open access) Delegated Regulation (EU) 2025/1920 on the unique identification of optical medical devices (spectacle frames, spectacle lenses and ready-to-wear reading spectacles) was published in the Official Journal of the European Union on September 23, 2025. It follows the public consultation we reported on earlier this year. We invite
[2025-08-15] Swissmedic, the Swiss Agency for Therapeutic Products, updated its “swissdamed” page on August 15, 2025. Swissdamed is the database for the registration of economic operators and medical devices, including in vitro diagnostic medical devices, on the Swiss market. Context The web page reminds us that swissdamed consists of two
[2025-08-27] In February 2024, the US Food and Drug Administration (FDA) published its final rule on the transition from the QSR (QS Regulation) to the QMSR (Quality Management System Regulation). This transition, intended to bring the regulations into line with ISO 13485:2016 and facilitate international harmonization, aims for an application
[2025-09-05] On September 5, 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a standard template for the post-market surveillance report (PMSR) for medical devices (MDs) and in vitro diagnostic medical devices (IVDDs). Context Post-market surveillance (PMS) is one of Great Britain’s priorities for the regulation of MDs
[2025-09-05] (Open access) Do you have a place at one of the upcoming EUDAMED workshops organized by the European Commission? The workshops, like the previous one held in Stuttgart on May 21, 2025, are free of charge, and always in a hybrid format: face-to-face and by videoconference. They will take
[2025-09-10] On September 10, 2025, France’s HAS (Haute Autorité de Santé) published a press release setting out the principles for evaluating Digital Medical Devices (DMDs). This press release, entitled “Dispositifs médicaux numériques : la HAS explicite ses principes d’évaluation” (Digital medical devices: the HAS clarifies its evaluation principles), reviews the
[2025-08-29] On August 29, 2025, Health Canada published new guidance for licence or authorization applications for groups of medical devices. This new 32-page guide is entitled “Guidance for determining medical device application type”, and is available in its entirety online. It can also be downloaded in PDF format, should you
[2025-05-30] The MHRA (Medicines & Healthcare products Regulatory Agency), the competent authority in the UK, announced on May 30, 2025 that it would be holding its next webinar on the “AI Airlock” project. AI Airlock is a “regulatorysandbox” created to meet the new challenges posed by medical device software using
