In March 2021 the European Commission published a guidance document titled “Questions and Answers on Custom-Made Devices”. The document includes high-level information “aimed at addressing the most pertinent questions relating to custom-made devices falling under the MDR”.
To view the guidance on Custom-Made Devices 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 Mar 2021EC publishes MDR guidance on Custom-Made Devices
- 01 Mar 2021EC publishes guidance addressing MDR requirements in the event EUDAMED is not fully functional
- 17 Feb 2021Register now for our HIBCC EU UDI Webinar
- 11 Jan 2021Register now for our HIBCC UDI Webinar
- 05 Jan 2021EC’s EUDAMED Actor registration module is now available