Insights

Vigilance procedures are a critical part of ensuring the safety and effectiveness of medical devices in the European Union. The Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 set clear requirements for manufacturers, authorized representatives, and other economic operators to monitor and report incidents involving medical devices. Understanding these vigilance requirements is essential for compliance and for prot

The European Union Medical Device Regulation (EU MDR 2017/745) introduced significant changes to the regulatory landscape for medical devices in Europe. Among these changes, the requirement for a Person Responsible for Regulatory Compliance (PRRC) stands out as a critical element to ensure ongoing compliance and patient safety. Understanding the role and responsibilities of the PRRC is essential for manufacturers, authorized representatives, and importers operating under the

The European Union’s Medical Device Regulation (EU MDR) 2017/746 introduced significant changes to the regulatory landscape for in vitro diagnostic medical devices (IVDs). One of the key requirements is the appointment of a Person Responsible for Regulatory Compliance (PRRC). This role is critical to ensuring that manufacturers meet their legal obligations and maintain the safety and performance of their devices throughout the product lifecycle. This post explores the role an