The requirements for the periodic safety update report are defined in Article 86 of the EU MDR 2017/745. Specifically, the PSUR should include:

• the conclusion of the risk-benefit analysis


• the main results of the post-marketing clinical follow-up


• Sales volume of the device and other characteristics of the population using it and, where possible, frequency of use of the device.

The PSUR must be prepared for each medical device or category of medical device and must include the results and conclusions of the post-market surveillance analyzes data collected as a result of the post-market surveillance plan together with a justification and description of any preventive actions and corrective measures undertaken.

Benefit-risk analysis

The benefit-risk analysis is part of the risk management process and must be performed throughout the life cycle of the medical device. The assessment of the risks and benefits of the device should be an ongoing process in which post-market supervisory information must be used.

Indeed, a different benefit-risk balance may emerge as supervisory data reveal additional safety information. The risk assessment of the device should be performed using post-market data.

Depending on the type of device involved, the following factors need to be considered during the risk assessment process:

• The number of cases (numerator) and the accuracy of the estimate, taking into account the source of the data;


• The amount and/or duration of use (denominator) expressed as the number of devices, patients, patient time, etc. And accuracy of the estimate;


• The frequency (calculated from the numerator and denominator) of a specific event;


• The impact on the individual patient (effects on symptoms, quality or quantity of life, reversibility);


• The impact on public health;


• Risks related to a specific population;


• Any patient risk factors (e.g. age, relevant co-morbidities, disease severity)


• The strength of the evidence and its uncertainties, including the analysis of the conflicting evidence, if applicable.

The main results of the post-marketing clinical follow-up

All completed and ongoing PMCF studies worldwide should be provided. The following information must be provided:

• Name or code of the study


• Name of the countries of study


• Number of study sites


• Number of patients enrolled and target number


• Number of serious accidents or deaths

Sales volume of the device

Based on the EU MDR, the PSUR will include an estimate of the number of devices sold. Devices should be grouped by basic UDI-DI level (or reference code level)

The number of devices supplied should be based on world sales volumes and should be split according to sales volume in the EEA + CH + TR and worldwide.

Depending on the type of product, the number of products placed on the market can be reported using one of the following issues:

• Total number of devices placed on the market or put into service


• Number of implanted devices


• Number of units distributed in a defined period


• Devices on the market, based on: Devices placed on the market or put into service


• Number of patient diagnostic tests or patient samples performed


• Number of usage episodes (for reusable devices)


• Active installed base


• Other (describe)

Also, if post-market use of the device has occurred in special populations, other information regarding the device's distribution numbers should be provided. Populations to consider could include:

• elderly population


• pediatric population


• pregnant or lactating women


• patients with hepatic and/or renal insufficiency;


• patients with disease severity other than that studied in clinical trials


• off label use