We have already reported on the objectives of the EU PSUR (“Periodic safety update report”) in the previous article. Following this introduction, we would now like to take a closer look at the new PSUR guidance published in December 2022, MDCG 2022 – 21 “Guidance on Periodic Safety Update Report According to Regulation (EU) 2017/745 (MDR)”.

As a reminder, the main objective of a PSUR is to provide a summary of the findings and conclusions resulting from the analyses of the post-market surveillance data of a device or device group. By evaluating all these reports, the previous benefit/risk profile of the medical device may change and, if necessary, require a re-evaluation of the benefit/risk ratio. The guidance considered in this article relates to medical devices under the MDR and the relevant Article 86. For in vitro diagnostic devices under IVDR (EU) 2017/746, there is also an obligation to write a “periodic safety update report” under Article 80, but the MDCG 2022-21 guidance is not applicable to these devices.

When is the manufacturer now obliged to provide a PSUR?

The preparation of the PSUR is only required for Class IIa (at least every two years), Class IIb and Class III (at least annually) medical devices that comply with the requirements of the MDR. In the case of the IVDR, Class C and D devices (at least annually) are concerned under Article 81. If necessary, it must also be updated outside the period, i.e. should unforeseen and serious risks arise or have arisen from the medical device. For Class I or Class A & B devices, there is an obligation to prepare a “post-market surveillance report” according to Article 85 or Article 80 and to update it if necessary.

What does all this mean exactly?

As stated in Article 86 (1) of the MDR, the results and conclusions of the analysis of post-market surveillance data collected under the PMS plan should be summarised and submitted. This includes:

  • the conclusions of the benefit-risk assessment;
  • the main results of the post-market clinical follow-up (PMCF);
  • the sales volume of the product and an estimated assessment of the size and other characteristics of the population using the product and, if possible, the frequency of use of the product.

It is generally important to collect records of serious as well as non-serious adverse events and adverse event data, and to include information from trend reports. In addition, information from relevant literature or technical literature, databases and/or registries should be considered. Also to be included is information such as feedback and complaints provided by users, distributors and importers. Also on the to-do list is to review publicly available information on similar medical products.

Frequently asked questions around the “Periodic Safety Update Report”.

Is the PSUR an eternal commitment?

Not at all! Of course, it is generally said that a PSUR is required throughout the life of the product. However, this only includes the time the product is expected to remain safe and effective for use / in use. If the lifetime exceeds the administrative requirements set out in Annexes IX, X, XI and XIII of the MDR, i.e. a maximum of 10 years for non-implantable devices and a maximum of 15 years for implantable devices, the shorter period between the lifetime of the device and the retention period should prevail.

Can I group several products in one PSUR?

It depends! If I have several basic-UDI DIs (or product families), they can be covered in one PSUR. However, this requires a justification for the relevance of the grouping (see also Article 86(1)).

What is a “Leading Device” in the PSUR?

If several product (model)s and thus several basic-UDI DIs are combined in one PSUR, the product with the highest risk class is designated as the “Leading Device”. If several products are in the same risk class, the manufacturer must define a leading device. The Leading Device is then used to define the key points of the PSUR for all basic-UDI DIs covered in the report (e.g. update period and frequency). If the Leading Device is changed or discontinued, the previous report must continue to be updated and a new report must be written for the new grouping. Each basic UDI DI can only be assigned to one PSUR as “Leading Device”.

Fair enough, but when do I have to start collecting data for the PSUR?

The data collection period should start from the date of MDR certification of the product. If the product is not MDR-certified but is still placed on the market under the transitional regime, the data collection period starts with the MDR validity date (26 May 2021).

What happens to my PSUR as long as EUDAMED is not yet fully functional?

In this case, the national regulations must still be observed. In addition, reports on class III devices or implants of any risk class (IIa, IIb or III) that are already certified according to MDR should be made available to the notified body after consultation. In principle, all manufacturers must hand over the reports to the competent authority on request. In addition to the information in MDCG 2022-21, the basic procedures for this can be found in MDCG 2021-1 Rev. 1 (MDs) or MDCG 2022-12 (for IVDs).

I need to create a PSUR for my IVD product. Where can I find assistance?

So far, there is no MDCG guidance explicitly addressing products under IVD Regulation (EU) 2017/746. It is hoped that a guidance will also be available for these products in the foreseeable future. Until then, however, the MDCG 2022-21 guide presented in this article can at least serve as a rough orientation.

And what should be considered for the “post-market surveillance report”?

This report must be prepared for Class 1 devices (MDR) and Class A and B diagnostic devices (IVDR). So far, there are no stand-alone guidance documents for the implementation of this requirement. Basically, the guidance for the plan refers to the same articles as the PSUR – namely Article 84 (MDR) or Article 79 (IVDR). Therefore, the basic considerations can also be applied to these products. In principle, it must be possible to submit the report to the authority upon request.

Your questions about the Periodic Safety Update Report according to MDR or IVDR have not yet been answered sufficiently? Do you find it difficult to identify clear data sources and to distinguish the type of data? Your QM system still needs optimisation with regard to post-market surveillance? seleon can help you with practical solutions – be it missing processes, support in data collection or complete outsourcing. Just get in touch with us.

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.