EU postmarket surveillance plans for medical devices.

PURPOSE

Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequence, the new EU medical device regulation was published; it includes the concept of a PMS Plan.

METHODS

This publication reviewed Annex III Technical Documentation on PMS and Annex XIV Part B: Postmarket clinical follow-up from the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.

RESULTS

The results of the PMS activities will be described in the PMS plan and will be used to update other related documents. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device.

CONCLUSIONS

The PMS plan may serve as a thorough tool for the benefit-risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.