The European Commission released a Question and Answer document containing information on the required procedures and standards for manufacturers of PPE (Personal Protective Equipment). The document will be updated on a regular basis in order to address additional questions and concerns.
To view the document click here.
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.
- 28 Jul 2020Register now for our second HIBCC UDI Webinar
- 27 Jul 2020EC releases conformity assessment procedures for manufacturers of protective equipment
- 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