Commission updates web page on MDR guidance
12 December 2019
Posted by: inetika
The European Commission has made changes to its list of guidance documents related to the forthcoming Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/756), which can be found here.
Revisions to the list include:
- Multiple guidances on Unique Device Identification (UDI)
- MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
- MDCG 2019-14 Explanatory note on MDR codes