EC Medical Devices Vigilance System and Post Marketing Surveillance
Ensuring that a medical device remains safe and effective whilst on the market is an essential part of complying with the EU vigilance and post-market surveillance requirements outlined in the Directive 94/42/2 EC.
Competent authorities carry out market surveillance activities to certify that all devices comply with the latest regulations, ensuring that all devices in the market are safe for users. Post-market surveillance requires the manufacturer to monitor and review
their devices to identify any needs for corrective action. This activity is carried out in conjunction with authorised representatives, importers and distributors and is a key element of the manufacturer’s quality control system. It forms part of a PMS plan, which if carried out effectively can reduce the risk of adverse events. Manufacturers are then legally obliged as part of a vigilance process, to report any serious incidents or correction measures to the relevant competent authorities.