The MDCG has updated a guidance document, initially published in 2019 regarding article 15 of the MDR and IVDR concerning the Person Responsible for Regulatory Compliance, commonly abbreviated to PRRC.
Among the plethora of updates that have been introduced in the guidance document, most notably, the new updated guidance document sees the following updates:
- Clarification on the qualifications needed to hold the role of the PRRC
- Clarification on PRRC requirements for Micro and Small Manufacturers
- Clarification on the roles and responsibilities of the PRRC of a manufacturer (Article 15(3))
- Clarification on the Entities assuming the obligations of a manufacturer
- Clarification on the Registration of the PRRC in EUDAMED
The updated guidance document can be accessed using the following link
