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

The European Commission has recently updated the MDCG 2023-3 Rev2 guidance, offering essential clarifications on the vigilance terms and concepts outlined in the EU Medical Device Regulation (MDR) 2017/745. This revision provides key updates to help stakeholders better understand the reporting obligations related to medical device safety.

The guidance focuses on critical elements of vigilance reporting, including detailed definitions of terms, such as serious incidents, field safety corrective actions, and adverse events. It emphasizes the importance of timely and accurate reporting by manufacturers, authorized representatives, and other parties involved in medical device safety. With this revision, the European Commission seeks to ensure that all parties involved in the lifecycle of a medical device remain compliant with the stringent safety standards established by the MDR.

The revised guidance also offers insight into the roles and responsibilities of manufacturers, distributors, and EU Member States when it comes to ensuring device safety, both pre- and post-market. By adhering to these updated guidelines, manufacturers will be able to enhance the safety of their devices, minimize risk to patients, and meet regulatory expectations in a more efficient manner.

For a more detailed understanding of the updated guidance, you can read the full document below.