Post-market surveillance

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.

What is post-market surveillance?

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.

And what’s its purpose?

Reasons why PMS activities are mandatory and required by the MDR can be summarized into three categories:

• Monitoring medical device safety and performance
• Meeting regulatory requirements – example: analysing and reviewing information to gain experience, feedback to the organisation for mandatory improvement activities
• Contributing to life cycle management – example: finding out whether or not the device remains state of the art, which could lead to design modifications or changes in intended use

How to start?

At the moment there are four important information/guidance sources to consider when developing a PMS system:

1. ISO/TR 20416:2020 Medical devices — Post-market surveillance for manufacturers; this guidance document was published in July 2020. It focuses on PMS and describes how to perform PMS in detail.
2. MDR 2017/745, which requires manufacturers to plan, establish, document, implement, maintain and update a post-market surveillance system according to Chapter VII Section 1, Articles 83 – 86.
3. ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes; since PMS is an integral part of the QMS, which also lists a couple of PMS requirements, it is advised to consider this standard.
4. ISO 14971:2019 Medical devices — Application of risk management to medical devices; this standard describes a few requirements that can be included in the PMS system and states how risk management can be used to analyse output of PMS.

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.

Why is it even necessary?

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.

When shall post-market surveillance be performed?

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.

Summarizing

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.