The PSUR: a complex puzzle with multiple dimensions

The PSUR (Periodic Safety Update Report) has become a mandatory component of the technical documentation for a medical device that must be provided to the notified body after the product has been placed on the market. MultiHealth explains what this new requirement entails.

In use for over 20 years in the field of medicine, the PSUR (Periodic Safety Update Report), also known as the periodic pharmacovigilance report, is an important source of information on adverse effects observed for a drug after it has been granted marketing authorization, as well as an assessment of the drug's benefit-risk balance.
Since May 2021, which marked the entry into force of European Regulation 2017/745 on medical devices, the PSUR is now a required document for medical devices (MD).

Among the new measures, manufacturers are now subject to stricter requirements in terms of monitoring the quality, performance, and safety of devices placed on the market.
This includes, in particular, the implementation of a post-market surveillance (PMS) system and the establishment of a PMS plan, as well as the drafting of periodic safety update reports (PSURs). These documents are now an integral part of the technical documentation for medical devices.

While the PMS plan outlines the processes and activities planned to monitor the safety and performance of the device after it has been placed on the market, the purpose of a PSUR is to present a comprehensive, concise, and critical analysis of the benefit-risk balance of a MD by integrating multiple pieces of information. The purpose of the PSUR is to demonstrate, as a manufacturer and with the help of objective evidence, that a post-market surveillance system has been deployed and that the data obtained from it is integrated into a broader risk management context that ensures the safety, performance, and effectiveness of the device.

An obligation that may continue beyond the lifetime of the medical device

The PSUR is required for Class IIa, IIb, and III MDs. Depending on the risk associated with the MD, the frequency of updates and submissions differs:
every 2 years for Class IIa, every year for Class IIb and III MDs/implantable devices. Any European competent authority or notified body may request the PSUR at any time during the product's life cycle. It is important to note that a PSUR is required for the lifetime of a device plus its shelf life, if applicable. For example, a single-use device may have a lifetime of one year and a shelf life of three years. The PSUR must therefore cover, be updated, and be made available for a total period of four years.
The PSUR process must be linked to the post-market surveillance plan, the risk management plan, the post-market clinical follow-up plan, and the clinical evaluation plan, where applicable. The content of the PSUR is briefly described in Article 86 of Regulation 2017/745/EU (1). There is also guidance written by the Medical Devices Coordination Group: " Guidance on periodic safety update report (PSUR) according to Regulation 2017/745."

Requirements by DM class

DM class	Document	Action	mission frequency
I	PMSR*	Updated when necessary	At the request of the authorities
IIa	PSUR	Provision of the notified body	Every 2 years
IIb	PSUR	Provision of the notified body	Every year
III + implantable	PSUR	To be submitted to the notified body via EUDAMED	Every year

A complex synthesis

Writing a PSUR is not something that can be improvised. The data required is extensive and diverse, requiring significant preparatory work to gather information from the relevant departments: regulatory, commercial, quality
, vigilance, etc. In this context, it can be very useful for the writer to have a checklist that they can update as information is received.
The data required includes:

• the date of CE marking (renewal) and marketing for all countries where the medical device is available,
• sales volumes by country and year,
• the size of the "exposed" population, the description of users, and the frequency of use,
• changes that may impact safety or performance,
• complaints and notifications reported by users or distributors,
• incidents with severity level, adverse effects, corrective safety measures,
• post-marketing clinical follow-up data (PMCFD),
• the literature review to identify benefits or risks associated with the medical device,
• quality actions taken in terms of correction and prevention (CAPA plan),
• risk analysis.

The PSUR summarizes the results and conclusions of the post-marketing surveillance data evaluation, including a justification and description of any corrective and preventive actions. All regulatory, commercial, clinical, quality, and vigilance data must be critically analyzed in terms of benefit-risk. In light of the conclusions reached, the final part of the PSUR describes the impact that the content of the PSUR will have on the subsequent post-marketing surveillance plan. In particular, a list of documents to be updated must be provided and the changes made or planned must be described.

In conclusion...

The PSUR is an essential document in the life cycle of a medical device, for regulatory reasons but also, and above all, to ensure patient safety. There are two key points to remember when producing a PSUR: plan ahead to ensure that multiple sources of information are collected for analysis, and always keep in mind the purpose of this type of report, which is to provide the most objective and accurate assessment possible of the benefit/risk ratio.

1 For DM-DIVs, Article 81 – IVDR 2017/746