Due to the global COVID-19 pandemic and the increased need for ventilators, the European Commission has published a guidance document on the regulatory requirements for ventilators and related accessories. The document “outlines the different regulatory options for placing these devices on the EU market indicating their feasibility to allow short term supply.”
To view the full EC document click here.
To learn more about HIBCC and UDI, visit www.hibcc.eu or contact HIBCC directly at firstname.lastname@example.org 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