Medtech

According to the European Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostics Medical Device Regulation (IVDR 2017/746), manufacturers are mandated to appoint a Person Responsible for Regulatory Compliance (PRRC). This individual holds explicit responsibility for ensuring post-market surveillance and obligations.

Specific educational and experiential requirements for PRRCs are necessary. These criteria include having a formal qualification from a university in fields such as law, medicine, pharmacy, engineering, or related disciplines, along with a year of experience in medical devices or quality management systems. Alternatively, individuals must have four years of professional experience in regulatory or quality management systems for medical devices, specifically focusing on European regulations.

RPN’s solution in this field includes:

• Identification and designation of the PRRC.
• Post-market surveillance set-up and maintenance.
• Coordination and assistance in handling complaints and reporting incidents to the Competent Authorities.
• Regular updates on regulatory changes that could impact devices and post-market surveillance requirements.
• Expert advice on effective post-market surveillance strategies.