BILLEV PHARMA EAST

NEWS

10 January 2024

Updated MDCG Guidance document MDCG 2019-07 Rev.1 released

On December 2023 Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) – MDCG 2019-07 Rev. 1 has been revised.

The guidance outlines on qualifications, responsibilities, and roles for the PRRC.

Article 15 of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) introduces the role of a Person Responsible for Regulatory Compliance (PRRC). This person is mandatory for manufacturers and authorized representatives, ensuring supervision and control of device manufacturing and post-market surveillance. The PRRC must meet specific qualifications, including a formal degree or relevant experience.

In this first revision, a few minor amendments have been made. Additionally, new sections have been added, stating that the PRRC shall suffer no disadvantage (Article 15(5)). Furthermore, there are clarifications on qualifications, custom-made devices, entities assuming the obligations of a manufacturer, and the registration of the PRRC in Eudamed.