The manufacturer’s obligation to proactively collect and review experiences obtained from medical devices already circulating on the market, and to apply any necessary preventive and corrective measures; or in other words post-market surveillance (PMS),is strengthened under the new Medical Devices Regulation (MDR).
According to Article 83 of the new Regulation, manufacturers shall set up, implement and keep up to date the PMS system, as one of the essential elements of their Quality Management System. Furthermore, the Person responsible for regulatory compliance (new Article 15) shall ensure that these PMS obligations are respected.
All classes of medical devices are concerned. Evidently, obligations are bigger for higher risk classes:
Manufacturers of class I devices shall prepare a Post-market surveillance reportsummarising the results and conclusions of the analyses of the PMS data and any corrective or preventive action taken;
Manufacturers of class IIa, class IIb and class III devices shall prepare a Periodic safety update report (PSUR) of each device, which shall set out conclusions of the benefit-risk determination, main findings of the Post-market clinical follow-up (PMCF); and the volume of sales. The PSUR for class IIb and III shall be updated annually; and for class III and implantable devices submitted to the Notified Body;
Manufacturers of implantable devices and class III devices shall also draw up a Summary of safety and clinical performance, which will be made public through EUDAMED.
With the new Regulation in force, the European Commission shall set up an electronic system on post-market surveillance and vigilance (Article 92).
To be ready in time for major changes introduced by the new Medical Devices Regulation, or if you wish to learn more about the CE marking or the EU compliance process, contact us today!