United Kingdom (UK) regulatory agency publishes HIBCC UDI template for use in medical device corrective action communications
The UK Medicines & Healthcare Products Regulatory Agency (MHRA) utilizes global UDI standards to communicate device safety information and corrective actions. Manufacturers are required to send Field Safety Notices (FSNs) and Field Safety Corrective Actions (FSCAs) to device users.
MHRA “considers it best practice to include unique device identifiers (UDIs) in field safety corrective action communications”. MHRA has published an easy-to-use template for including HIBC UDIs in FSNs and FSCAs. To view the HIBC UDI template on the MHRA website click here.
For more information on FSNs and FSCAs visit the MHRA website.
HIBCC is designated as an Issuing Entity by both the European Commission and the US FDA for their respective UDI initiatives. To learn more about HIBCC and UDI, visit www.hibcc.eu or contact HIBCC directly at email@example.com or +1 (602) 381-1091.
- 15 Jun 2020Register now for our HIBCC UDI Webinar
- 03 Jun 2020MedTech Europe releases guidance on Basic UDI-DI assignment for the EU MDR
- 28 May 2020United Kingdom (UK) regulatory agency publishes HIBCC UDI template for use in medical device corrective action communications
- 26 May 2020FDA UDI labeling and database submission deadline for Class I and unclassified devices rapidly approaching.
- 29 Apr 2020European Commission publishes guidance document on regulatory requirements for ventilators