Just before the end of the year, the Medical Device Coordination Group (MDCG) published a new guidance document (MDCG-2022-21) on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR). The PSUR is one of the new European requirements for higher-risk medical devices and in-vitro diagnostic medical devices (IVDs).
Under Regulation (EU) 2017/746 (IVDR), the PSUR is mandatory for manufacturers of class C and D IVDs and must be updated at least yearly throughout the device's lifetime. The requirements for the PSUR are described in Article 81 and Annex III.
The PSUR must include the following:
- the conclusions of the benefit-risk determination;
- the main findings of the post-market performance follow-up (PMPF);
- the volume of sales of the device, an estimate of the size and other characteristics of the population using the device, and, where practicable, the usage frequency of the device.
What are the requirements for IVDs based on this guidance for non-IVD medical devices?
First of all, MDCG 2022-21, like all MDCG guidance documents, clearly states that it is a guidance document, not legally binding, and also that it does not apply to IVDs. Nevertheless, this guidance provides valuable insights for IVD manufacturers on implementing the legal requirements for the PSUR. Moreover, the MDCG indicates in their overview of ongoing guidance documents "PSUR for MDR to be later adapted for IVDR," suggesting that the IVDR-specific guidance may be similar to the MDR guidance, at least for common aspects of MDR and IVDR.
For manufacturers of class A and B IVDs, for which no PSUR is required, the guidance may provide helpful suggestions on how information can be presented in the post-market surveillance (PMS) report required according to IVDR Article 80.
What about IVDD legacy devices?
For existing devices with an IVDD certificate or Declaration of Conformity, most PMS and PMPF requirements have also been applicable since May 26th, 2022. MDCG-2022-8 guidance on legacy devices clarifies that there are some exceptions, which include that no update is needed for documents that were not required under the IVDD, such as the Summary of Safety and Performance (SSP) and the Performance Evaluation Report (PER). Since the IVDD classification system is different from the IVDR, PMS results for all legacy devices may be reported in a PMS report (Article 80), and the generation of a PSUR (Article 81) is not needed. However, manufacturers still choose to generate a PSUR for legacy devices if they wish to do so.
Key points of MDCG-2022-21 and how to use them for IVDs
The PSUR is part of the technical file and should be generated as a stand-alone document that can be assessed independently from the supporting documentation. It should provide a general overview of all post-market surveillance activities and the data collected, and it should be analyzed based on the PMS plan for the device. Instead of duplicating all data and reports generated by the PMS Plan, the results and conclusions should be summarized. If specific data are not used or deemed not to be required, this must be justified in the PSUR.
The PSUR must consider all of the following elements (see IVDR Annex III, 1(a)):
o Information concerning severe incidents and field safety corrective actions,
o records referring to non-serious incidents and data on any undesirable side effects,
o information from trend reporting,
o relevant specialist or technical literature, databases and/or registers,
o information, including feedback and complaints, provided by users, distributors, and importers, and
o publicly available information about similar devices.
The PSUR template in Annex I of MDCG 2022-21 provides expectations and guidance on the structure and content of the PSUR. In Annex II, tables are provided on how to present the required information on sales volume, estimated size and characteristics of the population using the device, serious incidents, FSCA, and CAPA (related to the device).
- Grouping of devices
A PSUR should be drawn up per device (associated with one Basic UDI-DI (or one device for legacy devices)). Alternatively, a PSUR may cover a category or group of devices (multiple Basic UDI-DIs (or device families)); in this case, the manufacturer needs to justify the relevance of the grouping. In the PSUR for a group of devices, the data should be presented in a clear, organized manner so that it is easy to determine how each device performs independently. The manufacturer should assign a "leading device" which drives the schedule of that PSUR (data collection period covered, PSUR frequency, issuance timeline, PSUR reporting through EUDAMED or not) for the whole group. The "leading device" needs to be the highest or one of the highest risk classes.
- Timelines for issuance of PSUR and periodic updates
The data collection period should start at the device IVDR certification date. The end of the data collection period of the PSUR should be aligned with the anniversary date of the issued IVDR certificate or in an agreed schedule with the Notified Body.
If the device is not IVDR-certified (i.e., an IVDD legacy device), the data collection period starts at the IVDR Date of Application (DoA, May 26th, 2022). For the first PSUR, the data analysis may be supported by the device's historical data collected through PMS activities conducted prior to the IVDR DoA or IVDR Device Certification date. The "historical data" may be presented in a different format than the IVDR ones and could be limited to a summary.
When a legacy device becomes certified under the IVDR and no PSUR has been issued by the time of certification (e.g., the IVDR certification occurs within the first year after IVDR DoA or the device was self-certified), the PSUR should be prepared at the anniversary date of the IVDR certification or in alignment with the Notified Body.
Suppose an initial PSUR was issued for the legacy device before it became IVDR certified. In that case, the data collection period for the IVDR-certified device should start at the end of the data collection period for the PSUR drawn up for a legacy device. There is no need to consider the data before IVDR DoA since a PSUR for the corresponding legacy device has already been issued.
Yearly PSUR updates are required for all class C and D IVD devices. For class C devices, the PSUR must be made available to the notified body and, upon request, to competent authorities. For class D devices, the PSUR must be submitted to the notified body, which will make it available to the Competent Authorities on request. In the absence of EUDAMED, the PSUR should be delivered to the Notified Body.
- Presentation of serious incidents
Data regarding serious incidents should be reported using the International Medical Device Regulators Forum (IMDRF) Adverse Event Terminology, when available. For historical data, the usage of the IMDRF Adverse Event Terminology is not required. Serious incidents and their impact on the overall device safety should include an assessment of the data from at least three different perspectives: the device problems, the root cause, and the health effects on the person(s) affected. The IMDRF Adverse Event Terminology is suggested for assessing health impacts.
- Estimated size and characteristics of the population using the device
For IVD devices, this requirement refers to the patient population that the IVD is intended for, not the device's actual user. In the PSUR, the manufacturer should evaluate how many patients have been exposed to the IVD device and the characteristics of the exposed patient group(s). In addition, the usage of the device in different patient populations should be described and, when available, compared to the expected use. If clinically relevant and known by the manufacturer, possible over-represented or under-represented patient groups should be identified.
Still missing – guidance on trend reporting
MDCG 2021-22 needs more guidance on trend reporting which will be the scope of a separate guidance document. Until this new document becomes available, the most recent guidance on trend reporting continues to be MEDDEV 2.12.
Even though specific guidance for IVD PSUR is still pending, MDCG-2022-21 provides valuable insights into the expectations on scope, structure, and content of PSURs for IVD devices.
Generating and maintaining the PSUR and other PMS deliverables throughout the entire lifetime of IVD devices will consume time and resources to provide the level of rigor expected by the Notified Body and Competent Authorities. However, failure to maintain PMS, including yearly PSUR updates, can threaten the validity of a certificate. It is, therefore, essential to understand PMS and PSUR requirements and assign resources accordingly.
For IVDD legacy devices, it is even more important to understand the impact of post-market requirements under the IVDR and how to use existing PMS data as part of the performance evaluation required for the transition to an IVDR certificate. Even with the extension of the transition periods, planning and implementing the IVDR transition for your devices is essential.
Don't take your foot off the gas!
Qserve can help manufacturers understand the requirements of performance evaluation, including clinical performance and PMS under the IVDR. Understanding the expectations and the "how to" of writing plans and reports is essential for every organization. Let us help you rise to the challenge of these new requirements setting up processes and executing procedures.
Do you want to know more about Post Market surveillance or IVDR specific PMPF, PSUR?
Join our in-person IVD event in the UK on the 1st of February where these topics are discussed in the afternoon. (See agenda).