Updated MDCG 2023-3 Rev2 Guidance Clarifies Vigilance Terms for EU Medical Devices

The revised MDCG 2023-3 Rev2 guidance addresses key aspects of vigilance reporting under the EU Medical Device Regulation (MDR) 2017/745. It offers detailed definitions of critical terms, such as serious incidents, field safety corrective actions, and adverse events, while emphasizing the importance of timely reporting by manufacturers, authorized representatives, and other stakeholders. By clarifying roles and responsibilities across the medical device lifecycle, the updated guidance ensures compliance with stringent safety standards. Manufacturers and distributors can enhance device safety, minimize patient risks, and streamline their regulatory processes by adhering to these recommendations.