Since 26 May 2022, the IVDR requirements for Post Market Surveillance (PMS) are applicable for all IVD devices. Some manufacturers are not aware that, in addition to Class A devices that had to make the transition to the IVDR by May 26, 2022, for PMS requirements also class B, C, and D legacy devices should have already made the transition from IVDD to IVDR.
Although PMS is not new for IVD manufacturers, the requirements set by the IVDR are much more detailed than under the IVDD.
PMS under the IVDR
As a manufacturer, you are required to establish a PMS system for each device and this system must be an integral part of your Quality Management System (QMS).
Data collection for PMS should include:
- information concerning serious incidents (including information from Periodic Safety Update Reports (PSUR), and field safety corrective actions (FSCA)
- records referring to non-serious incidents and data on any undesirable side-effects
- information from trend reporting
- relevant specialist or technical literature, databases and/or registers
- information (including feedback and complaints) provided by users, distributors, and importers
- publicly available information about similar medical devices
A proactive and systematic process must be used to collect these data, together with effective and appropriate methods and processes for assessment of the collected data such as thresholds, indicators, and methods for trending.
The data gathered by the PMS system are used to:
- Update the Benefit-Risk Determination, Design and Manufacturing Information, Instructions for Use and Labelling, Performance Evaluation (PE), and the Summary of Safety and Performance (SSP).
- Identify needs for Corrective and Preventive Actions (CAPA), needs for FSCAs, and options to improve usability, performance, and safety of the device.
- Contribute to the PMS of other devices (where applicable).
- Detect and report trends.
The process and methods for collection and analysis of PMS data are documented in the PMS plan together with methods and procedures for continuous update of the benefit-risk analysis and to manage any detected event such as CAPAs and FSCAs.
A new and important subset of PMS under the IVDR is Post-Market Performance Follow-up (PMPF). Stay tuned for part 2 of this blog to learn more about PMPF under the IVDR.
Where to start with PMS implementation The first step for implementation is to ensure that PMS is implemented as an integral part of your QMS – make sure that your procedures cover the PMS requirements described in Article 78-81, Annex III, and Annex XIII Part B of the IVDR. Do not forget to establish links between PMS 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), and Periodic Safety Update Report (PSUR, for Class C and D).
For
each device a PMS Plan is needed, including a PMPF Plan (or a justification why PMPF is not applicable for this device). As a starting point for the PMS Plan define and justify similar devices, based on the intended purpose of your device and consider PMS data that are already available. See above for data sources that should be included. Consider to also include optional data sources such as production and post-production information or QC data. Make sure to include not only reactive data (such as feedback and complaints or information from trend reporting) but also collect proactive PMS data (e.g., by conducting surveys, expert/focus groups and PMPF).
Identify how you will collect each type of information, how frequently the data will be collected and how data will be assessed by whom and whether additional infrastructure or resource is need to achieve this. Identify indicators and threshold values for the assessment of the benefit-risk determination and link them to the risk acceptability criteria for your device and/or your risk management policy. Also include methods for trend detection, investigation of complaints and for communication with Competent Authorities, Notified Bodies, Economic Operators and users.
Required deliverables and frequency
PMS results are reported in either a PMS Report (for Class A and B) or a PSUR (for Class C and D). Results of PMPF are reported in a PMPF Evaluation Report for all devices. The table below shows the required deliverables per class:
For class C and D devices the PSUR must be updated annually. This implies that the first version of the PSUR should be issued 12 months after the IVDR certification has been received. For class A and B devices the frequency for updating the PMS Report must be specified in the PMS 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).
Note that for all devices additional updates may be needed, e.g., in case of serious 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 (for PMPF). 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 manufacturers may voluntarily choose to do so. Note that your PMS Plan should specify when and how often you will update the PMS Report, and this frequency should be proportionate to the risk of the device.
ConclusionPost-market surveillance is a continuing activity, it ensures that post-market experience is used to update technical documentation. 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. Failure to maintain PMS can threaten the validity of a certificate. It is therefore essential to understand PMS and PMPF and resources accordingly.
Read part 2: How to implement Post Market Performance Follow-up under the IVDR