Commission publishes the videos from the third EMDN training, the nomenclature behind every EUDAMED registration
Videos from the third European Medical Devices Nomenclature training were published on 3 August 2026. What the EMDN is, how…
Europe
europe updates on medical device regulation and quality.
39 articles
39 articles in Europe
Latest News
Latest News
European Commission publishes an updated list of notified bodies’ standard fees
The Commission published a refreshed list of notified bodies' standard fees on 13 July 2026. What the list contains and…
Latest News
Member States publish their 2025 monitoring reports on notified bodies under MDR and IVDR
The European Commission published Member State summaries of the 2025 annual monitoring and on-site assessment reports for MDR and IVDR…
Latest News
Swissmedic Updates Guidance: Packaging Leaflets for Healthcare-Only Medicines Optional
Effective December 1, 2025, Swissmedic, Switzerland’s therapeutic products regulator, has announced a significant change to its packaging guidance for human…
Latest News
Regulatory Update: MHRA Highlights November 2025’s Key Safety Insights for Medicines and Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued its latest safety roundup for November 2025, aimed at providing…
Latest News
Important Patient-Level Recall: Algifor Junior Suspension 200 ml and Algifor Dolo Junior Suspension 200 ml
Swissmedic issues a patient-centric recall for specific batches of Algifor Junior Suspension 200 ml and Algifor Dolo Junior Suspension 200…
Latest News
Critical Updates: Field Safety Notices Issued from 10–14 November 2025
Between 10 and 14 November 2025, significant Field Safety Notices (FSNs) were announced, carrying potential implications for stakeholders across clinical,…
Latest News
Swissmedic Expands Use of Breyanzi®: Updated Authorization Details
On November 22, 2025, Swissmedic announced the extension of the therapeutic indication for Breyanzi® (lisocabtagene maraleucel). This change has important…
Latest News
Swissmedic Updates: New Measures to Address Suicide Risk with Finasteride and Dutasteride
On November 18, 2025, Swissmedic announced new measures to mitigate the risk of suicidal thoughts associated with the use of…
Latest News
Swissmedic Releases Haemovigilance Annual Report 2024 With Key Findings on Transfusion Safety
Swissmedic, the Swiss agency for therapeutic products, has published its Haemovigilance Annual Report for the year 2024. The report evaluates…
Latest News
Swissmedic Announces Enhanced Use of Enhertu® for Extended Therapeutic Indications
Swissmedic, Switzerland’s regulatory authority for therapeutic products, has announced the authorization of an extended therapeutic indication for Enhertu®. This update…
Latest News
Swissmedic Opens Bids for Advanced Document and Records Management System: A Regulatory Update
On November 3, 2025, Swissmedic, the Swiss agency for therapeutic products, announced its initiative to procure a state-of-the-art Document and…
Loading more articles…