Periodic Safety Update Report

Long awaited and widely anticipated, the guidance paper MDCG 2022-21 "Guidance on Periodic Safety Update Report According to Regulation (EU) 2017/745 (MDR)" was published shortly before the turn of the year 2022/2023. Dr. rer. nat. Timo Weiland summarizes the key takeaways from the document.

Patient Safety as a Cornerstone of the MDR

Already in the recitals to the MDR, the European Parliament and the Council of the European Union set out that manufacturers are obliged to establish, as part of their quality management system, a mechanism that allows the behavior of a medical device to be monitored during routine use. This Post-Market Surveillance (PMS) system is designed to inform decisions on necessary measures to ensure the safety of patients and users. The underlying data are generated through the systematic and proactive collection of real-world use experience from a wide variety of sources.

This is not a new concept, as both the MDD and EN ISO 13485 had already required the maintenance of an appropriate PMS system.

The PSUR as a Communication Channel

Collecting data, however impressive in scope, is of limited value if the results are not properly processed and transparently communicated to the relevant stakeholders. On one hand, this includes the competent authorities and notified bodies, who are "served" through the Periodic Safety Update Report (PSUR). On the other hand, the public – in the form of the informed patient – is kept informed through the Summary of Safety and Clinical Performance (SSCP).

Accordingly, the PSUR – pursuant to Article 86 of the MDR – summarizes the results and conclusions of the analysis of data gathered through PMS in accordance with the PMS plan over a defined reporting period.

The PSUR

• provides a snapshot of the current safety and performance of the device,
• assesses any potential change in the benefit-risk profile,
• provides information on CAPAs, and
• compares the intended purpose and use of the device – both qualitatively and quantitatively – against the real-world use environment and the patient population involved.

The structured reporting to notified bodies and competent authorities on device performance in real-world use requires a uniform, standardized, and systematic presentation of PMS data by manufacturers of Class IIa, IIb, and III devices.

Structured PSUR Preparation in Accordance with MDCG 2022-21

Article 86 has already been discussed in detail in our specialist article for Gesundheitsindustrie BW.

Manufacturers were, however, left somewhat to their own devices, as beyond the statutory requirements of Article 86, no further guidance was provided on exactly how such a structured summary of data should be presented.

As a result, manufacturers and service providers such as novineon CRO GmbH took the initiative and developed pragmatic approaches to fulfilling the PSUR obligation. The document MDCG 2022-21 responds to this situation. Manufacturers should be given sufficient time to adapt their quality management systems accordingly. It is also not (yet) expected that PSURs that have already been prepared or are currently in preparation fully comply with this MDCG document, provided they satisfy the requirements of Article 86.

A word of caution is, however, warranted. Some notified bodies take a different view on this point. Furthermore, the progressive alignment of existing PSUR structures with MDCG 2022-21 will become increasingly necessary going forward.

Subject Areas to Be Covered Within PMS and the PSUR

The scope of PMS data to be collected and the required level of detail depend primarily on:

• the type of device,
• the duration of time on the market, and
• prior PMS experience.

For detailed questions regarding when, for which device, and with what data a PSUR is to be prepared, reference is made to the presentation delivered by novineon at the virtual Lunch event. At this point, we would briefly like to highlight the following key aspects of PSUR preparation:

• The PSUR should be structured and documented in a clear, well-organized, searchable, and unambiguous manner, and must include an Executive Summary.
• It should be a self-contained, independently readable document, while retaining a purely summarizing character – without unnecessary detail.
• Marketing claims form part of the technical documentation and must also be consistent with the clinical evaluation and the instructions for use.
• Standardization principle: the MDCG 2022-21 template should be followed step by step, to the extent practicable. Each section must therefore be addressed, and any missing elements must be justified.
• A PSUR reference number and sequential version number must be assigned – with respect to data collection periods, these must be presented continuously, without gaps, and in a transparent manner.
• A "leading device" must be defined in the case of a device group.
• The required data structure for sales volumes and complaints must be established in accordance with the MDCG 2022-21 template, to the extent practicable.
• Sales volume data should be specified with appropriate justification – use should be estimated in a justified manner, using appropriate units and appropriate granularity with respect to variants.
• Every anomaly must be discussed, including the corresponding measures taken.
• A clear statement must be provided as to whether the "positive" benefit-risk ratio continues to be maintained.

Ultimately, the legislator's interest lies in a transparent approach and in building a continuous database that allows for comparison between clearly defined, consecutive data collection periods.

The overall PMS process should not be conceived from the perspective of the PSUR alone – the PSUR is a periodic compilation of data. The PMS process itself is an ongoing activity and must be structured in such a way that deviations are identified promptly and countermeasures can be initiated without delay.