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Commission updates web page on MDR guidance

  • Posted by: inetika
  • Category: GLOBAL NEWS

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