Post-market Surveillance: PSUR in Two Steps

Section I of Chapter VII of Regulation (EU) 2017/745 addresses the topic of post-market surveillance. To complement the subject, the MDCG 2022-21 – Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 is also helpful.

Surveillance by manufacturers, like vigilance – a different but recently updated topic – is certainly not new. However, the level of detail and repeatability of the data collection and analysis phases required have certainly changed.

Here we have decided to present the high-level scheme that we apply to our clients, to share what we consider the most straightforward approach to address the topic.

Before continuing the discussion, it’s important to be clear that the ultimate purpose of surveillance activities is to:

• Update the risk-benefit assessment and improve risk management;
• Update design and manufacturing information, instructions for use, and labeling;
• Update the clinical evaluation;
• Update the summary of safety and clinical performance;
• Identify the need for preventive, corrective and safety corrective actions;
• Identify possibilities to improve the usability, performance, and safety of the device;
• If applicable, contribute to the post-market surveillance of other devices; and
• Identify and report trends.

Step 1: Research, Collection, and Preliminary Analysis

The surveillance activity can be thought of as divided into two steps, the first concerning an activity of research and collection of input data and the initial compilation – in accordance with respective plans – of the periodic safety update report (PSUR) and, if applicable, the post-market clinical follow-up (PMCF) report.

The above must be repeated for each individual Basic UDI-DI and Legacy device subject to surveillance because, according to MDCG 2022-21 and except for situations that can be evaluated individually, a PSUR must be created for each basic UDI-DI and Legacy device.

From this first phase, two scenarios can materialize. The first arises when the input information, for example, does not exceed previously defined threshold values, or confirms situations already analyzed previously, and more generally, there is a clear and evident absence of new and noteworthy elements.

In this case, it’s easy: it’s a matter of formalizing in the reports the reasons that lead to not considering it necessary to initiate consequent actions and closing the activity.

It’s different if, from carrying out the first step of the post-market surveillance activity, data should emerge that have a potential impact on the points that represent the purpose of the entire activity. In this case, it is necessary to start the second step.

Step 2: Impact Assessment and Consequent Actions

The second step, in cases where it is applicable, is closely related to what emerged from the research above and concerns the analysis of the impact of the input elements, the completion of reports and the consequent initiation of corrective and preventive actions, including updating the technical documentation involved.

Precisely because of its nature, this phase may involve the initiation of long and complex activities that could see the involvement of the notified body, the management of design changes, or even the need for notification to the Competent Authority.

The reports (PSUR and PMCF) must therefore be completed with a summary of the impact of the input data, a description of the activities initiated to manage what emerged, and the related timelines.

The Periodicity of Post-Market Surveillance

The issue of periodicity could be somewhat controversial.

The Regulation expresses itself as follows:

Manufacturers of class I devices shall prepare a post-market surveillance report, updated when necessary.
Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years.
Manufacturers of class IIb and III devices shall update the PSUR at least annually.

“When necessary”. When is it necessary?
Excluding class IIb and III, for which it’s easy; for the other classes, we give our interpretation, certainly conservative.

“Updating the PSUR” is not synonymous with “carrying out post-market surveillance”. Surveillance activity is a continuous activity, the formalization of which, at most, can be dated with the performance of the two steps above.

Therefore, keeping the division into two steps valid, it is clear that the first step must be carried out periodically regardless of the class. This phase is the only one that can generate the need for updating the PSUR: it is precisely from this phase that the “when necessary” mentioned above could derive.

Then, if from carrying out the first step no noteworthy elements should emerge, it would be legitimate for class I manufacturers not to update the PSUR and for class IIa manufacturers to update it every two years.

Despite this, however, once the data has been collected, does it really make sense not to keep track of it somewhere?

Our short answer is that carrying out step 1 and the consequent updating of the PSUR (or the surveillance report, for class I), regardless of the class, should be done at least once a year.
Albeit with the usual margin of movement, sustainable, to embrace the needs of realities with greater difficulties in terms of resources.