Complying with EU IVDR Postmarket Surveillance (PMS) Requirements

Once the IVDR takes effect, roughly 85% of all IVDs will be subject to Notified Body oversight. As such, manufacturers will be expected to compile detailed technical documentation prior to obtaining CE Marking certification or placing their device on the EU market. A critical piece of that documentation includes your plans and procedures for postmarket surveillance (PMS) a fancy name for ensuring the ongoing safety and efficacy of your device. Despite the name and regardless of device risk, PMS occurs before and after your IVD is placed is on the European market.

Chapter VII, Article 78(1) of the IVDR makes this quite clear: For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device.

For many diagnostics manufacturers, the IVDR PMS requirements are in uncharted territory, as this is a fairly new requirement under the regulation. Because of that, we have prepared this brief overview to give you a sense of what is required of IVD manufacturers. Let’s start with the basics.

What Is Postmarket Surveillance?

PMS is a comprehensive process for monitoring and assessing the safety and performance of medical devices and IVDs. It starts before the device is placed on the European market and continues for the entire life cycle of the device. It is an ongoing process, not a one-time project.

To be effective and compliant with the IVDR, PMS needs to be:

• Systematic (happens regularly)
• Active (not just waiting for complaints to be reported)
• Documented (exactly how you did it and what the results were)

Notified Bodies are required to carry out audits at least every 12 months including an assessment of your PMS planning, data analysis, and reporting so it is important that you actually execute on the three points noted above. In addition, Notified Bodies are required to conduct unannounced audits at least once every five years.

Assemble Your Reference Documents

While Articles 78-81 and Annexes III and XIII of the In Vitro Diagnostic Regulation (2017/746) tell you what needs to be done with regard to postmarket surveillance, details on how to meet those requirements are sparse. Therefore, after you download this version of the IVDR (which contains a super-useful linked table of contents), take a look at the European Commission website (which fills in some of the knowledge gaps of the documents). New details are released monthly, so be sure to bookmark the European Commission website page.

• IMDRF guidance A consortium of national regulators (including the EU) who cooperate to harmonize medical device and IVD regulations where possible. There are some useful IVD-specific documents on this site, and it’s likely you’ll want to monitor documents posted here.

• ISO/TR 20416:2020 This is an important guide to implementing PMS for IVD (and medical device) manufacturers. While this standard is general in nature and does not override any EU regulations, your Notified Body will expect you to follow its recommendations.

• ISO 20916:2019 Provides detailed information on how to plan, design, conduct, record, and document premarket and postmarket IVD clinical performance studies.

• WHO PMS guidance If you aim to participate in the World Health Organization’s Prequalification of In Vitro Diagnostics Programme, reading this guide to postmarket surveillance is essential. While its requirements have nothing to do with the IVDR, it contains useful information nonetheless.

Critical Elements of an IVDR-Compliant Postmarket Surveillance Program

You’ll read many terms in the IVDR and it’s easy to get them confused. Here’s a quick primer. The table that follows contains further information on what is required

• Postmarket surveillance plan (PMS plan or PMSP) Successful outcomes often start with a solid plan. In the case of the IVDR, it’s not a suggestion it is a requirement. Annex III, Section 1 of the IVDR outlines the basic framework of PMS plan contents. However, the real meat of your plan will be driven by the manufacturer requirements set forth in IVDR Chapter VII, Articles 78, 79, and 81. Also see Annex III.

• Postmarket surveillance report (PMSR) Required for Class A and B devices only, this report is used to summarize results and conclusions of PMS activities. See IVDR Article 80.

• Periodic safety update report (PSUR) Required for Class C and D devices, this report is also used to summarize results and conclusions of PMS activities. See IVDR Article 81.

• Postmarket performance follow-up (PMPF) This is a continuous process of updating IVD safety and performance evaluation data after the device is placed on the European market, the method of which is linked to the postmarket surveillance plan. Results are documented in a PMPF report, which is linked to your risk management activities and the performance evaluation report (PER). PMPF may not be required for some devices, with justification. See IVDR Annex XIII, Part B.

• Performance evaluation report (PER) An assessment of IVD scientific validity, analytical performance, and clinical performance. Performed as needed for Class A and B devices, and at least annually for Class C and D devices. Requirements are spelled out in Annex XIII, Part A, 1.3.2 of the IVDR. Read this IVD PER post for more details.

• Clinical performance studies These studies are needed when existing analytical performance studies, published literature, or routine device use are not adequate to establish or confirm specific aspects of a devices clinical performance. If this is needed, a clinical performance study plan (CPSP) must be prepared. See IVDR Annex XIII, Part A, Section 2.

Core Elements of IVD Postmarket Surveillance

*PMPF may not be required for a specific device if the manufacturer can justify the reason for not doing so.

Beyond CE Marking Certification

The IVDR requires manufacturers to be proactive about collecting postmarket surveillance data but does not spell out exactly what to do, how deep to go, and how often to do it. The reason is that PMS activities are very much dependent on the risk associated with the device. Clearly, the extent of PMS activities associated with a low-risk Class A device will differ from that for a high-risk Class D device. Also, the way you go about collecting postmarket surveillance data depends on whether your IVD is a simple consumer product or a sophisticated professional-use test. Here are some common proactive PMS activities that manufacturers often use as part of their ongoing monitoring efforts:

• Postmarket performance studies
• Written or online surveys
• Literature searches
• Using medical device registries
• Social media monitoring tools
• Adding QR codes/phone number/URL to labeling to make it easy to contact you or access your complaint-reporting page
• Learning from preventive actions and risk assessments
• Setting up a system for sales/account managers to share field feedback
• PMPF studies
• Published recall information

Annex A of ISO/TR 20416:2020 includes numerous examples of proactive data sources. Your efforts must be documented, and you can bet that your Notified Body will absolutely check your efforts during your annual surveillance audits. Waiting around for complaints to arrive in your inbox does not count as an active process, as postmarket surveillance should be a continuous activity within a company.

Getting Started

Figuring out where to begin with PMS planning can be a bit overwhelming. Fortunately, you don’t need to go it alone. Oriel STAT A MATRIX offers a variety of training courses to help get you on the right path to compliance, including our IVDR training course and postmarket surveillance course. Our team is also available to assist with all aspects of IVDR compliance should you need it.