europe updates on medical device regulation and quality.
258 articles
On September 30, 2025, Hikma Farmacêutica (Portugal) S.A issued a notification to the Medicines and Healthcare products Regulatory Agency (MHRA)…
Swissmedic, Switzerland’s regulatory authority for therapeutic products, has reaffirmed its position on the use of medicines containing paracetamol during pregnancy.…
Important updates for clinical, quality, and regulatory teams: A series of Field Safety Notices (FSNs) were published between 8 and…
Swissmedic has officially authorised VANFLYTA®, marking its initial regulatory approval. This announcement, dated September 30, 2025, highlights a significant development…
Healthcare professionals and regulatory teams, please take note. Between 15 and 19 September 2025, a range of Field Safety Notices…
On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew as a member of the International Medical Device…