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…
Regulatory Affairs
Global updates on medical device regulation and quality.
70 articles
70 articles in Regulatory Affairs
Europe
Europe
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…
Europe
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
FDA opens the MDUFA V reauthorisation to public comment as the current authority runs to September 2027
FDA held its public meeting on reauthorising the Medical Device User Fee Amendments for FY2028 to FY2032 on 5 August…
Latest News
FDA Appoints Acting Director for Center for Drug Evaluation and Research
The U.S. Food and Drug Administration (FDA) announced the appointment of Tracy Beth Høeg, M.D., Ph.D., as the acting director…
Latest News
FDA Issues Early Alert on Glucose Monitor Sensor Risks from Abbott Diabetes Care
The FDA has issued an Early Alert regarding a significant safety concern involving certain glucose monitor sensors manufactured by Abbott…
Latest News
Critical Update: Olympus Modifies Use Instructions for Single Use Ligating Device PolyLoop
On December 3, 2025, the FDA announced a significant correction related to Olympus’s Single Use Ligating Device PolyLoop. This update…
Latest News
FDA Issues Urgent Recall for SJM Pericardial Patch Due to Quality Control Issue
An urgent recall has been announced for a specific lot of SJM Pericardial Patch devices distributed by Glycar SA. Health…
Europe
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…
Europe
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
FDA Issues Serious Correction Notification for BD Alaris Pump Modules Due to Safety Risks
The United States Food and Drug Administration (FDA) has released an updated correction notification for BD Alaris pump modules. These…
Europe
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…
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