As described in part 1 of this series, since May 26, 2022, the IVDR requirements for Post Market Surveillance (PMS) and Post Market Performance Follow-up (PMPF) are applicable for all IVD devices, including not only class A but also class B, C and D legacy devices. Some manufacturers are not aware that their legacy devices that still need to make the transition from IVDD to IVDR already must comply with the IVDR requirements for PMS and PMPF.
PMPF is a new and important subset of PMS under the IVDR. PMPF is used to continuously update the performance evaluation of IVD devices that bear the CE marking throughout their expected lifetime. The main goals are to confirm the safety, performance (including the clinical benefit if applicable) and scientific validity of the device, to detect any emerging risks and identify possible systematic misuse of the device.
Where to start with PMPF implementation
The first step is to ensure that PMPF is implemented as an integral part of your QMS – make sure that your procedures cover the PMPF requirements described in Annex XIII Part B of the IVDR. Do not forget to establish links between PMPF and risk management, CAPA, performance evaluation and Summary of Safety and Performance (SSP). Create templates for the required deliverables such as the PMS Plan, PMS Report (for Class A and B), Periodic Safety Update Report (PSUR, for Class C and D), PMPF Plan and PMPF Evaluation Report.
Remember that the PMS Plan needs to include a PMPF Plan and is needed for each device (class A, B, C and D). Alternatively, a separate PMPF Plan could be written and referenced in the PMS Plan. If PMPF is deemed not appropriate for a specific device, a justification must be provided in the Performance Evaluation Report (PER) [IVDR Annex XIII 1.1 last paragraph]. Since the main goals of PMPF are to confirm the safety, performance and scientific validity of your device, PMPF may not be needed if the safety of the device when used in clinical practice has already been completely confirmed during the performance evaluation and risk management. If there are any outstanding risks, uncertainties about the performance of your device when used in clinical practice or the performance of the device may change over time (e.g., due to change of clinical practice, occurrence of new viral strains) you have to perform PMPF.
In the PMPF Plan specify the general and specific methods you will use to collect and evaluate safety, performance and scientific data for your device after it has been placed on the market. General methods include feedback from users, clinical experience gained and scientific literature searches. Specific methods could be participation in ring trials, epidemiological studies, evaluation of suitable patient or disease registers or PMPF studies. To identify specific methods for your device, review your PER including indications for use, intended population, clinical safety and performance requirements, clinical claims and clinical benefits. Identify any gap(s) in the clinical data and to formulate questions that should be addressed by PMPF. Consider any outstanding residual risks and how to address these by e.g., user surveys or performing additional usability studies.
If you perform scientific literature searches to collect information on safety and/or performance of devices placed on the market, make sure that the search is structured and uses systematic data extraction to meet the requirements of Annex XIII. If you want to know more about literature searches and techniques refer to this blog by Josh Spencer on Systematic Literature Search (https://bit.ly/3Cx6UGT) or the virtual training on literature search for IVDs hosted by Jasmin Hunter (https://www.qservegroup.com/eu/en/e1180/clinical-suite--literature-search-for-ivds).
When analyzing feedback from users and scientific literature pay attention for any systematic misuse of your device such as off-label use (e.g., use of the device for different indications, different sample types, different populations). Note that systematic misuse should not be confused with use errors. Modification of a device by a healthcare institution including use for a different intended purpose or combining different devices is covered by the in-house exemption if the healthcare institution complies with the requirements set in IVDR Article 5.5.
Required deliverables and frequency
Results of PMPF are reported in a PMPF Evaluation Report for all devices. A summary of the PMPF results is included in the PMS Report (for Class A and B) or the PSUR (for Class C and D). The table below shows the required deliverables per class:
For all devices the frequency for updating the PMPF Evaluation Report must be specified in the PMPF Plan and should be proportionate to the risk of the device (higher frequency e.g., for new technology, high impact on the patient or new to the company). For class C and D devices a yearly update of the PMPF Evaluation Report is highly recommended since PMPF serves as input for updating the PER and the PSUR. Notified bodies will expect the commitments made in the plans will be kept so it is important to check that their preparation remains on track. PMS and PMPF will be a key focus of the notified boy surveillance activity, it takes time and resource to properly implement and will jeopardize certificate renewal if not completed.
Note that for all devices additional updates may be needed, e.g., in case of serious adverse events, significant trends in complaints, emerging risks or previously unknown performance issues and limitations.
What about IVDD legacy devices?
For existing devices with an IVDD certificate or Declaration of Conformity the majority of PMS and PMPF requirements are also applicable. The recently published guidance MDCG-2022-8 on legacy devices clarifies that there are exceptions for premarket requirements: No update is needed for documents that were not required under the IVDD, such as the SSP, and the PER. Since the IVDD classification system is different from the IVDR, for all legacy devices PMS results may be reported in a PMS report and generation of a PSUR is not needed, but manufacturer may voluntarily choose to do so. Note that your PMPF Plan should specify when and how often you will update the PMPF Evaluation Report, and this frequency should be proportionate to the risk of the device.
Conclusion
Post Market Performance Follow-up is a continuing activity that ensures that the performance evaluation of an IVD device remains up to date throughout its entire lifetime. PMPF requirements are effective now and are required for the vast majority of devices. It will consume time and resources to provide the level of rigor expected by the Notified Body, but failure to maintain PMS including PMPF can threaten the validity of a certificate. It is therefore essential to understand PMS and PMPF and assign resources accordingly.
Qserve is able to help manufacturers understand the requirements of PMS and PMPF under the IVDR. Understanding the expectations and the “how to” of writing plans and reports is important for every organization. Let us help you rise to the challenge of these new requirements setting up processes and executing procedures.
Read part 1: How to get started with Post Market Surveillance under the IVDR.