What is post-market surveillance?
Post-Market Surveillance (PMS) refers to the set of activities aimed at proactively collecting and analyzing experience gained on marketed medical devices, throughout their life cycle.
Post-Market Surveillance includes all passive (or, better, reactive) and proactive activities, which make it possible to obtain useful data to keep information on the quality, performance and safety of a medical device already on the market continuously updated.
Who is involved in post-market surveillance?
Post-Market Surveillance is conducted by each manufacturer in collaboration with other economic operators (such as authorized representatives, distributors, and importers) for the devices they place on the market, make available on the market, or put into service. They are responsible for implementing activities aimed at establishing and maintaining a systematic procedure for proactively collecting and analyzing experience gained from their medical devices. The purpose is to identify any need for immediate implementation of corrective or preventive actions.
What are examples of PMS activities?
PMS activities can be classified into two main groups:
- Passive (or reactive) PMS activity and
- Proactive PMS activities.
Reactive (or passive) PMS concerns activities that the manufacturer implements as a reaction to an external event; for examples: complaints, identification of problems in production, technical support records (e.g., returns of defective products), spontaneous reports of device misuse or customer satisfaction, vigilance and recall.
On the other hand, proactive PMS activities include all activities implemented by the manufacturer to proactively collect information about its device, such as PMCF (post-market clinical follow-up) activities, post-market studies, questionnaires distributed to customers, feedback from users collected during device training activities, etc.
The level and type of proactive PMS activities must be evaluated by the manufacturer based on the risk class of its medical device.
What is the purpose of post-market surveillance?
The systematic process of collecting information from the market about marketed medical devices, driven by both passive and proactive PMS activities, is not only a regulatory requirement imposed by the EU Regulations 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices but is also essential for systematically and continuously facilitating:
- the development of improved medical devices in terms of performance and technology.
- the early identification of concerns, adverse effects, and new risks related to marketed medical devices and the immediate action by the manufacturer and/or Competent Authorities.
- the identification of off-label uses of devices.
All of the above activities have common goals, such as innovation and development of safe and performing technologies that rise above the State of the Art, protection of medical devices users/patients health and public health.
Therefore, post-market surveillance should be considered a systematic and proactive process aimed at ensuring, throughout the life cycle of medical devices, their safety, usability, and performance, compared to the State of the Art.
In fact, it is very often difficult, if not impossible, to be able to comprehensively predict, already at the premarket stage, all potential risks, side effects or even all possible uses of a medical device, as well as to foresee developments in innovative technologies. It is during the post-market phase, when the medical device is available on the market and its use by the population is widespread, that new information not considered or unpredictable during the pre-market phase might emerge.