Post-Market Surveillance: Post-Market Surveillance Reports

With the first anniversary of the MDR approaching, so too is the end of the first evaluation period for post-market surveillance. Having collected data through the post-market surveillance system, the time has now come to analyze and summarize those findings. Dr. rer. nat. Benedikt Fabry of novineon CRO describes in the following article the differences between the various reports and where the primary focus should lie when preparing them.

Few requirements of the MDR have caused as much discussion among medical technology companies as the "manufacturer's post-market surveillance system" described in Chapter VII – a title whose very unwieldiness commands a certain respect. In everyday use, the English term "Post-Market Surveillance," abbreviated as PMS, has therefore become the established standard.

However, the PMS system is not an entirely new requirement introduced by the MDR, as the Medical Devices Directive 93/42/EEC (MDD) had already required a systematic procedure for evaluating post-manufacturing experience with products (Annex II, Section 3.1). The post-market surveillance plan described in Article 84 of the MDR was likewise already addressed in the Medical Devices Directive 93/42/EEC (Annex X, Section 1.1c).

What is genuinely new in the PMS system, however, is the requirement for regular reports summarizing the results, analyses, and conclusions drawn from the data collected through the PMS system.

This is consistent with the general direction of the MDR to bring all relevant areas of medical device commercialization into systematic and traceable processes. The resulting sequence of plan and report is already familiar from other processes, such as the clinical evaluation.

The Types of Reports Are Clearly Defined

For Class I devices, a post-market surveillance report (MDR Article 85) – also referred to as the PMS Report – is required.

For all other devices, a Periodic Safety Update Report (MDR Article 86) is required. This report is referred to below as the PSUR, in accordance with the abbreviation of its English designation.

In summary, the de facto static system of the MDD is substantially dynamized by the MDR. Reports are actively required and subject to an explicitly defined periodicity.

The MDR not only clearly defines which type of report must be prepared for which device, but also how frequently the report must be prepared or updated (see table). Both reports are to be understood as tools for communication with Notified Bodies and competent authorities, designed to facilitate seamless information exchange.

For custom-made devices, the PSUR forms part of the technical documentation pursuant to Annex XIII, Section 2, and should therefore, in accordance with MDR Article 2(3), be integrated into it. As with other medical devices, the update cycle and assessment of the PSUR are governed by the applicable risk class.

Table:

Overview of the time periods to be covered and the addressees of reports within the PMS system. For custom-made devices pursuant to MDR Article 2(3), the PSUR additionally forms part of the documentation pursuant to Annex XIII, Section 2.

PMS Report or PSUR: The Differences

The MDR stipulates that the PMS system must be proportionate to the device. Accordingly, the PMS Report is only to be updated as needed and made available to the Notified Body upon request. In terms of content, the PMS Report is also less comprehensive than the PSUR required for higher-risk class devices.

The PMS Report summarizes the data collected through post-market surveillance. Its primary objective, however, is to describe and justify any preventive and corrective actions arising from the data generated by the PMS system.

Given the higher risk involved, the PSUR for Class IIa, IIb, and III devices is considerably more extensive. In addition to the information required for the PMS Report, the PSUR must also include the key findings of the clinical evaluation and the conclusion of the benefit-risk assessment. It must further include the total sales volume of the device, including (where practicable) an estimate of the number of users and/or patients and the frequency of device use.

This report must be made available to Notified Bodies on a regular basis for review. In the case of Class III devices and implants, the PSUR and the assessment are additionally forwarded to the competent authorities.

Both reports serve solely to summarize the information gathered. The definition of PMS measures, their implementation, and the evaluation thereof are decoupled from these reports and are to be found in the PMS Plan.

A Standardized Template

The Medical Device Coordination Group is currently developing guidance on the PSUR, which is intended to facilitate the uniform reporting of relevant information to Notified Bodies and competent authorities. The publication of this guidance document was planned for the second quarter of 2022.

The document is eagerly anticipated by many stakeholders. This is because even manufacturers of Class I devices – who are not directly required to submit their PMS findings – may find the PSUR template of interest as a basis for establishing uniform internal documentation.

Impact on the Clinical Evaluation

The results of the PMS system, along with clinical data and the technical documentation, form the basis for the clinical evaluation of the device. Carefully coordinating the clinical evaluation with the preparation of the PMS Report or PSUR can significantly reduce the overall workload.

For implants and Class III devices in particular, the typically annual update cycles of both the clinical evaluation and the PSUR allow certain tasks to be synchronized – such as the presentation of sales figures and complaints, or searches of regulatory authority databases – ensuring that current information is used consistently across all documents. Summary text blocks can also be reused across multiple documents.

This approach may equally be appropriate for Class I devices, for which the clinical evaluation is updated less frequently. Here too, regular documentation can facilitate subsequent work.

Conclusion

• The PMS Report and the PSUR complete the PMS system, which follows the plan–execute–report cycle frequently required by the MDR.
• Both documents serve as a means of communicating PMS results and the resulting measures to Notified Bodies and competent authorities.
• Until the publication of the MDCG guidance on the PSUR, it is important to maintain a concise, highly structured document that is independently readable.
• In terms of content, the following points should be covered: scope, device reference, and data relating to the defined reporting period.
• By synchronizing the update cycles of the PMS system reports and the clinical evaluation, the time required for both documents can be reduced.