Requirements for post-market surveillance (among a host of other requirements for everything from classification to clinical follow-up) were never that elaborate in the In Vitro Diagnostics Directive (IVDD; 98/79/EC).
However, with the introduction of the In Vitro Diagnostics Regulation (IVDR, 2017/746), the requirements for in vitro diagnostics devices (IVDs) were updated to match the requirements for medical devices.
The update led to various new and updated concepts and requirements for IVDs, some of which had only been seen in the medical device world until then.
Post-market surveillance (PMS) was one of the concepts that got a major overhaul in the IVDR, and we frequently get questions from IVD manufacturers who aren’t entirely clear on what they need to do to be compliant.
In this article, we review the most frequently asked questions on post-market surveillance for IVDs and attempt to help you move forward on the path to compliance.
What is PMS for IVDR?
Post-market surveillance (PMS) is defined in the IVDR as:
“…all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.”
Simply put, post-market surveillance is collecting data on your device’s behavior in the market and using the collected data to ensure your device is safe and efficient.
As such, post-market surveillance is a proactive and systematic process that must be performed throughout your device’s lifetime.
The definition of post-market surveillance in the IVDR matches that of the Medical Device Regulation (MDR, 2017/745).
Why do I need post-market surveillance for an in vitro diagnostics device?
The short answer is: that it’s a requirement under the IVDR. Thus, you need it for compliance.
The longer answer is to do with patient and user safety.
Any device manufacturer, whether talking medical or in vitro diagnostic devices, sets out to manufacture a high-performing and safe device.
The goal is to help patients and, essentially, to save lives.
And while you might take all the precautions you can to make your device safe during the manufacturing process, there is only one way to ensure your device remains safe in the hands of your patients and users.
Yup, you guessed it – post-market surveillance.
Post-market surveillance is how you monitor your device after it has reached the market. Y
our PMS system should be designed to review complaints, adverse event data, clinical follow-up, and trends to update your technical documentation, risk management system, performance evaluation, and quality management system to make your device as safe as possible.
Which other parts of my technical documentation does my post-market surveillance data impact?
Post-market surveillance data must be collected throughout the lifetime of your device, and any information gathered through your post-market surveillance system potentially impacts many other parts of your technical documentation.
The PMS system, as outlined in Article 79 (3) of the IVDR, should be used to:
- Update the benefit-risk analysis and improve risk management
- Update the design and manufacturing information, the instructions for use, and the labeling
- Update the performance evaluation
- Update the summary of safety and performance
- Identify preventive, corrective, or field safety corrective actions
- Identify ways to improve the device by improving device usability, performance, and safety
- Contribute to post-market surveillance for other devices
- To detect and report trends
As you can see, compliance under the IVDR is interconnected – one set of activities impact the other activities in the system.
As such, post-market surveillance data has the potential to impact every other part of your technical documentation.
What are the deliverables in my post-market surveillance system?
Post-market Performance Follow-Up (PMPF)
Post-market performance follow-up (PMPF) is required for all classes of IVDs. Some IVDs may be deemed exempt, in which case a thorough justification must be provided in the performance evaluation report.
PMPF is used to update the performance evaluation of IVDs to confirm the device’s safety, performance, and scientific validity and to determine any emerging risks or systematic misuse.
PMPF is a natural bridge between raw post-market surveillance data and performance evaluation in that it confirms the safety and performance of the device throughout its expected lifetime and identifies previously unknown risks or performance limits, or new emerging risks.
It should also identify any possible misuse or off-label use of the IVD.
PMPF plans, and reports must be updated at least annually for manufacturers of Class C and D IVDs and when necessary for manufacturers of Class A and B IVDs, which generally means at least every three years.
Post-market Surveillance Report and Periodic Safety Update Report
The post-market surveillance report summarizes the post-market surveillance activities performed in a determined period.
It analyzes the collected data of the period and provides results and conclusions based on that PMS data.
The PMS report should also provide rationales and descriptions of preventive and corrective actions.
The post-market surveillance report and its corresponding post-market surveillance plan are required of manufacturers of Class A and B IVDs.
It should be updated when necessary, generally at least every three years.
The periodic safety update report (PSUR) is equivalent to the PMS report for Class C and D IVDs manufacturers.
In addition to the contents of the PMS report, the PSUR should also conclude on the continued acceptability of the device’s benefit-risk profile, provide device sales volumes, evaluate the size and characteristics of the device population, as well as usage frequency, and offer any post-market performance follow-up findings.
The PSUR should also do a benefit-risk analysis to determine if the benefits of using the device still outweigh the risks.
Manufacturers of Class C IVDs should update the periodic safety update report at least every two years. In contrast, manufacturers of Class D IVDs should update the report at least every year.