MDCG Issues Guidance on PRRC and Implant Cards
2019/07/01
On July 1st the European Commission released two new guidance documents. The first, MDCG 2019-7, is focussed on Article 15 of the MDR and IVDR regarding a “Person Responsible for Regulatory Compliance” (PRRC) and the second, MDCG 2019-8, is focussed on the implant card required under Article 18 of the MDR.