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.
MDCG 2019-7 regarding the PRRC clarifies that:
- A PRRC must be appointed for each legal manufacturer. This implies that if a parent company has several legal manufacturers, in each legal entity a PRRC must be appointed.
- The location of the PRRC of the manufacturer must allow the establishment of a close link, of a permanent and continuous nature, between the PRRC and the manufacturing activities. Therefore, for a manufacturer based outside the EU the PRRC can be located outside the EU, and for manufacturers based within the EU the PRRC should be based within the EU.
- The location of the PRRC of the Authorised Representative (AR) is assumed to be based in the EU as the AR is based in the EU.
- The PRRC of the manufacturer should not be the same person as for the AR.
- If the role is of PRRC is outsourced by the manufacturer as well as by the authorised representative of that manufacturer, then the PRRC shall not belong to the same external organisation.
The MDCG 2019-8 regarding the Implant Cards provides guidance on a blueprint of an implant card required under the MDR. It describes the intended use, content and information to be provided by a manufacturer together with the implant card as well as providing a definition of fields to be completed by the implanting healthcare institutions or healthcare providers. This guidance introduces symbols that should be used on the implant card and the concept of an instruction leaflet to accompany the card. Several examples have been included in the document.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.