Purpose: Purpose:Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarketing 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.

Additional Metadata
Keywords medical devices, pharmacoepidemiology, postmarket surveillance plan, risk management, safety evaluation
Persistent URL dx.doi.org/10.1002/pds.4859, hdl.handle.net/1765/118456
Journal Pharmacoepidemiology and Drug Safety: an international journal
Pane, J. (Josep), Francisca, R.D.C. (Reynold D.C.), Verhamme, K.M.C, Orozco, M. (Marcia), Viroux, H. (Hilde), Rebollo, I. (Irene), & Sturkenboom, M.C.J.M. (Miriam C.J.M.). (2019). EU postmarket surveillance plans for medical devices. Pharmacoepidemiology and Drug Safety: an international journal. doi:10.1002/pds.4859