The International Medical Device Regulators Forum (IMDRF) held a two-part workshop on September 11 and September…
Category: Europe
europe updates on medical device regulation and quality.
Profemur Modular Neck Hip Implants: Heightened Risk of Fractures and Revision Surgery Identified
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an important update regarding the risks…
IMDRF Digitalizes Membership Applications: New Online Platform Launches
Clinical, quality, and regulatory teams take note: Starting May 2025, the International Medical Device Regulators Forum…
Scemblix® Gains Extended Therapeutic Indication Approval from Swissmedic
Swissmedic has officially announced an extension of the therapeutic indications for Scemblix®, a drug that plays…
Regulatory Alert: Patient Information Leaflet Defect for Hikma Farmacêutica’s Gemcitabine 2g/52.6ml Infusion Concentrate
On September 30, 2025, Hikma Farmacêutica (Portugal) S.A issued a notification to the Medicines and Healthcare…
Regulatory Update: Swissmedic Confirms Safety of Paracetamol Use During Pregnancy
Swissmedic, Switzerland’s regulatory authority for therapeutic products, has reaffirmed its position on the use of medicines…
Critical Updates: Field Safety Notices Issued from 8–12 September 2025
Important updates for clinical, quality, and regulatory teams: A series of Field Safety Notices (FSNs) were…
Swissmedic Grants Initial Authorisation for VANFLYTA®: Impact on Clinical and Regulatory Practices
Swissmedic has officially authorised VANFLYTA®, marking its initial regulatory approval. This announcement, dated September 30, 2025,…
Critical Updates: Field Safety Notices Issued for Medical Devices (15–19 September 2025)
Healthcare professionals and regulatory teams, please take note. Between 15 and 19 September 2025, a range…
GHWP Announces Voluntary Withdrawal from IMDRF Membership
On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew as a member of…