MDR / IVDR Article 15: Person Responsible for Regulatory Compliance (PRRC)
Article 15 of both the regulations the In-Vitro Medical Device Regulations (IVDR) and Medical Device Regulations (MDR) have important new requirements for hiring a ‘person Responsible for Regulatory Compliance’. With the new EU MDR 2017/745 and IVDR 2017/746, ensuring the competent personal in the right position is not only important from the business point of […]