One of the new requirement introduced with the EU MDR 2017/745 is the one related to the preparation of the Periodic Safety update Report (PSUR). This type of report is quite well known in the pharmaceutical world but it is considered a new requirement in the medical device sector.
What is the PSUR?
The Periodic Safety Update Report is basically a document summarising post-market surveuillance data of the device. The PSUR is not mandatory for all the devices but it is only for specific classes of medical devices, as per the table below:
|Device Class of Risk||PSUR|
For class I device, the periodic safety update report is replaced by a post-market surveillance report.
What are the contents of the Periodic Safety Update Report
The requirement for the Periodic Safety Update Report are defined in the Article 86 of the EU MDR 2017/745. Specifically, the PSUR shall include:
- the conclusion of the benefit-risk analysis
- the main findings of the post-market clinical follow-up
- sales volume of the device and other characteristics of the population using the device and, where practicable, the usage frequency of the device.
The PSUR shall be prepared for every medical device or medical device category and shall include the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken.
Benefit Risk Analysis
The benefit-risk analysis is part of the risk management process and it has to be performed throughout the lifecycle of the medical device. The evaluation of the risks and the benefit of the device shall be a continuous process where post-market surveillance information shall be used. In fact, a different Benefit-risk balance may emerge as vigilance data reveals further information about safety.
The risk assessment of the device shall be performed by using post-market data. Depending on the type of device involved, the following factors should be considered during the risk assessment process:
- The number of cases (numerator) and precision of estimate, taking into account the source of the data;
- The extent and/or duration of use (denominator) expressed as numbers of devices, patients, patient-time, etc., and precision of estimate;
- The frequency (computed from numerator and denominator) of a specific event ;
- The impact on the individual patient (effects on symptoms, quality or quantity of life, reversibility);
- The public health impact;
- The risks related to a specific population;
- Any patient factor relevant to risk (e.g. age, relevant co-morbidity, disease severity)
- The strength of evidence and its uncertainties, including analysis of conflicting evidence, ifapplicable.
The main findings of the post-market clinical follow-up
Any completed and ongoing PMCF studies worldwide should be provided. The following information should be provided:
- Name or code of the study
- Name of study countries
- Number of study sites
- Number of patients enrolled and the target number
- Number of serious incidents or deaths
Sales volume of the device
Based on the EU MDR the PSUR shall include an estimate of the number of devices sold. The devices should be grouped by basic UDI-DI level (or reference code level). .
The number of devices provided should be based on the worldwide volumes of sales and should be broken down to the volume of sales in EEA + CH + TR and Worldwide.
Depending on the product type, the number of products placed on the market can be reporting 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 within a defined period
- Devices on the market, based on: Devices placed on the market or put into service
- Number of tests diagnostic tests on patients or patient samples performed
- Number of episodes of use (for reusable devices)
- Active installed base
- Other (describe)
Moreover, where post-market use of the device has occurred in special populations, other information regarding device distribution numbers should be provided. Populations to be considered could include:
- elderly population
- paediatric population
- pregnant or lactating women
- patients with hepatic and/or renal impairment;
- patients with other relevant co-morbidity
- patients with disease severity different from that studied in clinical studies
- off label use
How frequent shall a Periodic Safety Update Report be documented?
The requirement to prepare the PSUR start at the date of the application of the MDR, which at the moment is set for 26 May 2021.
The frequency related to the documentation of the Periodic Safety Update Report by the manufacturer depends on the class of risk of the device.
Specifically, for medical device of Class IIa the PSUR shall be prepared on a biannual base and it is reviewed by the notified body during the conformity assessment review. For medical device of Class IIb or class III, the PSUR shall be documented at least once a year.
The preparation of PSURs should continue throughout the lifetime of the device even in the case where the certificate for the device may be withdrawn.
Who Shall Review the PSUR?
According to EU MDR 2017/745, the Notified Body shall annually review PSURs for Class III and implantable devices. For Class IIa and IIb devices, the devaluation shall be performed during the surveillance audit.
The document Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation should be utilize through sampling.
The competent authorities may also request and review PSURs as part of their vigilance investigations, clinical trial reviews and market surveillance activities. The results of their evaluation will be/ will not be added to the database.
QualityMedDev E-Book on Post-Market Surveillance
QualityMedDev recently published e-book of 36 pages that provides a practical guideline to post-market surveillance activities according to EU MDR 2017/745. This document represents a comprehensive overview of the medical devices PMS requirements for the European market. After all the changes introduced through the MDR, there has been the necessity of one unique document that explains and discusses the medical device post-market surveillance requirements.
Specifically, the topics covered by the e-book are:
- ISO 20416:2020 and the New Requirements for Post-Market Surveillance Activities for Medical Devices
- Deep Dive in the Post-Market Surveillance (PMS) Processes according to EU MDR 2017/74
- The Post-Market Clinical Follow-up
- Requirements Periodic Safety Update Report according to EU MDR
- Template for Periodic Safety Updated Report according to European Medical Device Regulation
- Vigilance Reporting Requirements according to EU MDR 2017/745
This Guideline on Post-Market Surveillance (PMS) Activities provides an overview of new processes such as PMCF (Post-Market Clinical Follow-up) and PSUR (Periodic Safety Update Report) and it includes as well an example of PSUR template. Moreover, an overview of the vigilance reporting system according to EU MDR 2017/745 is discussed.
We have been giving an in depth overview of the requirements related to the Periodic Safety Update Report according to EU MDR 2017/745. The PSUR is a new requirement for medical device sector and it is applicable for high risks device, from Class IIa to Class III.