Navigating PSUR Requirements under the Medical Device Regulation (MDR)

Periodic Safety Update Report (PSUR) is one of the key components of the Medical Device Regulation (MDR 2017 745) developed by the European Union under Article 86 to guarantee the ongoing evaluation of the medical device safety and efficacy after it goes to the market. PSUR becomes a very important document for the manufacturers to examine and identify problems that could arise with regard to the use of their products after release onto the market based on the information obtained through post marketing surveillance (PMS).

PSUR: Definition and Significance?

• PSUR (Periodic Safety Update Report)   medical devices

• It is a safety update on the performance of the medical device under scrutiny carried out in order to ensure the safety and performance of the product after its market release.

Device identification and scope

• Precise device(s) specification including model/version and use.

• Whether the report refers to a family of the devices or just one product.

Benefit Risk assessment

• Brief and concise benefit risk evaluation on whether the benefits still outweigh the known or potential risks taking into account the latest information.

Post Market Clinical Follow up (PMCF) summary

• Brief description of post marketing clinical follow up data collection including any newly discovered safety and performance data.

Analysis of Sales and Use data

• Information on sales volume, user population and usage information providing clues of any adverse trends.

Post Marketing Surveillance (PMS) findings

• Information obtained through various sources, e.g., incidents reporting, users' comments, technical literature and others.

Corrective and preventive action (CAPA)

• Any safety related actions implemented and planned to address any risks or adverse effects identified during PMS or PMCF activities.

Conclusions and summary

• General conclusion regarding safety and performance of the device, whether benefit-risk remains favorable and the need for updating risk management information.

Administrative information (if applicable)

• Where needed (for Class III and implantable devices) relevant administrative information including reference number, version and involvement of the Medical Device Notified Bodies.

Importance of the PSUR

• As the PSUR constantly monitors performance of the device in practice, it is possible to detect all adverse effects and assure that the product is safe and effective for further use.

PSUR (Periodic Safety Update Report) frequency requirements based on device class

Class IIb & Class III Devices

• The manufacturer is obliged to revise and submit a PSUR for such devices at least once per year.

• This report has to be provided one year after the approval date of the device or when it will be converted into the new MDR (Regulation 2023/607).

• It does not matter whether the MDR evaluation has been fully done yet; manufacturers have to respond to any changes immediately.

Class IIa Devices:

• The manufacturers of such devices are supposed to submit a PSUR at least once every two years.

• Nevertheless, in some situations, more frequent submissions may be required.

Class I Devices:

• PSUR is not applicable for Class I devices that belong to either measuring, reusable or sterilized categories

Custom Made Devices:

• In the case of custom made medical devices, the PSUR is mandatory documentation that must be provided under the regulations of Annex XIII of the MDR. This ensures that the safety and performance of the device are continuously monitored even after manufacture and distribution.

Legacy Devices (as per MDD/AIMDD):

• Legacy devices are those medical devices which were authorized under the old directives i.e. Medical Device Directive (MDD) 93/42/EEC or Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC prior to the Medical Device Regulation (MDR 2017 745).

• The CE mark indicates that the product meets the basic safety and health requirements outlined under the European legislature.

These regulations ensure that medical devices are consistently assessed for safety and performance, with adjustments made as new information emerges over their lifetime.

Timeline for PSUR Preparation and Content

Following the data collection, the manufacturer needs to prepare the PSUR within the specified timeline. The process needs proper planning beforehand in order to be able to accomplish it on time.

Content of PSUR

The report should contain the following information:

• Cover Page: Information about manufacturer/device, NB, PSUR reference/revision, period of data, and table of contents.

• Executive Summary: Actions performed since last PSUR, actions by NB, benefit risk status statement.

• Device Description & Intended Use: Classification, dates, status, purpose, Basic UDI DIs/EMDN, rationale for grouping.

• Sales & Population Information: Units Sold, Population Size & Population Characteristics

• PMS Information: Incidents of concern (incidents coded according to IMDRF guidelines), trend information, FSCA report & CAPA activities.

• PMCF & other PMS Sources: Complaints, scientific literature, registries, public data, other sources.

• Specific PMCF activities: Results of studies and conclusions made from the studies.

PSUR Submission and Review Process

PSUR submission guidelines are different depending on the device category:

• Class III and Implantable Devices: In such categories, electronic submission of the PSUR to the Notified Body responsible for the device’s conformity assessment should be done. The Notified Body assesses the report which is afterwards submitted to the European Database of Medical Devices (EUDAMED).

• Other Device Categories: PSURs need to be made available to the Notified Body and competent authorities in case they request such information. This can be requested during normal surveillance processes or due to certain safety signals about the device.

Ensuring Compliance:The Crucial Role of the PMS Plan

Article 83 of the MDR mandates that manufacturers develop a post marketing surveillance (PMS) plan describing the approach they would use to gather and analyze safety and performance data from various sources including:

• Incident Reports: Safety data from serious and non serious incidents related to the device.

• User Feedback: Performance data from users about the use of the device in the market.

• Technical Literature: Research findings on the device or other similar devices.

• Publicly Available Information: Safety and performance data on other similar devices.

This is an important requirement for manufacturers to meet the regulatory standards set out under the MDR.

Implementing PSUR Requirements: Key Guidance for Manufacturers

The MDCG 2022-21 guidance was issued in December 2022 and provides recommendations for manufacturers to be able to meet PSUR obligations. Among other important clarifications in the guidelines is the definition of such an important concept as "device certification date." The guidelines outline the process of submission of PSUR for legacy devices. Although manufacturers are strongly recommended to update their quality management systems in accordance with these regulations, certain flexibility is still acceptable, provided that the basic compliance with Article 86 is achieved.

Conclusion

The Periodic Safety Update Report (PSUR) is key to ensuring that the safety and effectiveness of medical devices continue to be maintained throughout the entire lifecycle of the product. With the requirement for frequent updating and evaluation of post marketing surveillance (PMS) data set by the Medical Device Regulation (MDR), risks can easily be identified and dealt with in order to maintain safety levels for both users and regulatory authorities. It is imperative that medical device manufacturers adhere to the requirement to submit and update PSURs.

Any further clarification on PSUR requirements can be sought from the Notified Body.