Abstract
PurposeRecent 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.MethodsThis 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.ResultsThe 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.ConclusionsThe 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.
Highlights
A medical device is defined as “any instrument, apparatus, appliance, material, or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease, replacement, or modification of the anatomy or of a physiological process, and control of conception.”[1]. Medical devices are a great resource for enhanced diagnosis and disease management
The Poly Implant Prothèse (PIP) breast implant scandal in 2012 affected thousands of women and damaged the confidence of the different stakeholders involved in postmarket surveillance (PMS) of medical devices.[2]
Another incident in 2012 involving hip implants raised a public health concern: metal‐on‐metal total hip replacements were successfully implanted, but metal abrading against metal caused erosion and leaching of metal particles into soft tissue.[3]
Summary
A medical device is defined as “any instrument, apparatus, appliance, material, or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease, replacement, or modification of the anatomy or of a physiological process, and control of conception.”[1]. The Poly Implant Prothèse (PIP) breast implant scandal in 2012 affected thousands of women and damaged the confidence of the different stakeholders involved in postmarket surveillance (PMS) of medical devices.[2] More than 400 000 women around the world received PIP implants that were made of industrial‐grade silicone gel, prone to rupture, leading to inflammation and irritation Another incident in 2012 involving hip implants raised a public health concern: metal‐on‐metal total hip replacements were successfully implanted, but metal abrading against metal caused erosion and leaching of metal particles into soft tissue.[3] Such metal debris weakens tissue and bone around the implant, leading to implant failure, requiring additional surgery. The manufacturers did not provide an adequate response to the competent authorities with regard to these adverse events and there was always the belief that they could have been avoided.[4]
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