MDCG publishes guidelines on the MDR/IVDR regulations
EU's Medical Device Coordination Group (MDCG) has published two guidance documents, MDCG 2019-7 and MDCG 2019-8, regarding the Medical Device Regulation (EU) 2017/745 (MDR) and in vitro Diagnostic Device Regulation (EU) 2017/746 (IVDR).
The document MDCG 2019-7 concerns the requirement in Article 15 in both regulations regarding the "(…) person responsible for regulatory compliance" (PRRC). It deals with the requirements for the person's qualifications as well as roles and responsibilities associated with the task as PRRC.
MDCG 2019-8 provides guidance on the so-called implant card (IC) required by Article 18 of the MDR. Among other things, the document describes the data elements, which must appear from an IC, and gives examples of the design of an IC.
Both documents stress that they are not European Commission documents and do not necessarily reflect the official position of the Commission. Therefore, the documents are not legally binding.
The MDR will come into force May 2020, while the IVDR will come into force May 2022, following a transition period in order to make sure manufacturers, notified bodies and authorities may comply with the changes.
Read the two guidelines here:
- MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a "person responsible for regulatory compliance" (PRRC)
- Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.