The what, how, why and when of a post-market surveillance system
It is generally known that, before placing a medical device on the market in Europe (from the 26th of May, 2021), it shall comply with requirements from the MDR.
Manufacturers of medical devices must fulfil all General obligations of manufacturers listed in Article 10. One requirement states that a quality management system shall be implemented, including a system for post-market surveillance.
This also counts for class I medical devices which are allowed to be placed on the market under MDD till 26 May 2024. For these class I devices, MDR requirements regarding: post-market surveillance, market surveillance, vigilance and registration requirements become mandatory 3 years prior to this date. Wonder why this post-market surveillance (PMS) system is so important? This article will explain the what, how, why and when of the newly introduced PMS system.
The MDR requires manufacturers of medical devices to have a post-market surveillance system in place. Its goal is to actively and systematically gather information from devices that are put on the market (e.g. complaints, scientific literature), analyse this information and draw conclusions. The output gives an indication about the quality, safety and performance of the medical device. PMS output is to be fed back into various QMS processes to ensure ongoing compliance to regulatory requirements and enables the continuous improvement of quality based on experience gained from post-production activities.
Reasons why PMS activities are mandatory and required by the MDR can be summarized into three categories:
At the moment there are four important information/guidance sources to consider when developing a PMS system:
All three standards are complimentary to each other in terms of requirements for (post-)production activities to conduct post-market surveillance. ISO/TR 20416 essentials are shown in the flowchart below and give a high level overview of how to set up and maintain a PMS system.
ISO/TR 20416 describes in its very first sentence exactly why PMS is mandatory:
As medical devices are designed, developed, manufactured and distributed on the global market, a residual risk with regard to the medical device’s safety and performance remains throughout the product life cycle.
During the life cycle of the device there will always be residual risks that remain in terms of safety and performance. How is this possible, even after using risk controls?
The second sentence states:
This is due to a combination of factors, such as product variability, factors affecting the medical device’s use environment, the different end user interaction, as well as unforeseen
medical device failure or misuse.
As shown, the first two sentences of ISO/TR 20416 say that residual risks remain throughout the life cycle of the medical device and why. To make sure the residual risks of the device stays ‘acceptable’ information of safety and performance of the devices in use shall be collected and analysed. The information shall also be used in other processes.
It was mentioned before that residual risks remain throughout the life cycle of the medical device. Therefore PMS shall be performed during the complete life cycle of the device and the extend of PMS activities shall be proportionate to the risk class and type of device. For class I devices a post-market surveillance report shall be written which includes the results and conclusions of the data analysis. It shall be updated when necessary. For class IIa, class IIb and class III devices a periodic safety update report (PSUR) shall be written which includes the same topics as the post-market surveillance report, but is updated more frequently.
Setting up a PMS system requires access to multiple documents, whereas each document contains its own requirements. List these requirements, implement them in your QMS system and write clear procedures proportionate to the medical device. This, together with an ongoing PMS feedback loop, will lead to a properly developed PMS system and maintains the devices safety and performance.
Please contact us if you have any questions regarding PMS.