Question:
We are a manufacturer of in-vitro diagnostic medical device software. How do we ensure the post-market surveillance under the IVDR?
Short answer:
Read my ultimate post-market surveillance guide and check the IVDR, Chapter VII and Annex III.
Long answer:
The Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR) forces you to monitor your device after placing it on the market. The basic idea is to track the device’s safety and performance in the field. This principle is called post-market surveillance (PMS).
For many diagnostics manufacturers, these IVDR post-market surveillance requirements are unfamiliar territory, as they are relatively new under the regulation. To help you understand what is expected of IVD manufacturers, we have prepared this brief overview. Let’s start with the basics.
The key post-market surveillance Articles in the IVDR
Chapter VII, Article 78(1) of the IVDR clearly states that manufacturers must plan, establish, document, implement, maintain, and update a post-market surveillance system for each device. This system must be proportionate to the risk class and suitable for the type of device.
Post-market surveillance (PMS) is a comprehensive process for monitoring and assessing the safety and performance of medical devices and in vitro diagnostics (IVDs). This process begins before the device is introduced to the European market and continues throughout its entire life cycle. PMS is an ongoing activity, not a one-time effort.
To comply with the IVDR and to be effective, post-market surveillance must be:
- Systematic: Conducted regularly.
- Active: Identifiy problems proactively and prevent complaints.
- Documented: Detailed records of methods and results.
The regulatory background and cheat sheet
Articles 78-81 and Annexes III & XIII of the IVDR. These sections outline the essential steps required for compliance, focusing on post-market surveillance (PMS). They detail the creation and maintenance of a Post-Market Surveillance Plan, PMS Report, and Periodic Safety Update Report (PSUR), specifying the necessary update intervals. Essentially, the higher the risk classification of your device, the more frequently you need to revise and update your technical documentation.
The PMS plan outlines the search and how you analyze data about your device’s performance in the field and similar devices. The content, the name and the update cycle of the report depends on the risk class. There are three kinds of reports. Here is the comprehensive overview:
| Risk class | Report type | Update cycle | Regulatory reference |
| Class A | PMS Report | When necessary | IVDR, Article 80 |
| Class B | PMS Report | When necessary | IVDR, Article 80 |
| Class C | Periodic Safety Update Report (PSUR) | At least annually | IVDR, Article 81 |
| Class D | PSUR | At least annually | IVDR, Article 81 |
The good, the bad and the guidance
The IVDR does not tell you how to do post-market surveillane. But don’t worry, because the international regulatory community got you covered.
MDCG Guidances
The Medical Device Coordination Group (MDCG) frequently releases guidance documents on post-market surveillance. Therefore, I strongly recommend reviewing the following guidance documents:
MDCG 2022-9 Summary of safety and performance
MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (You can recycle a lot of information from the MDR. Believe me.)
IMDRF
The international medical device regulator’s forum (IMDRF) is a consortium of different regulatory bodies. They published a very good guidance on PMS that provides you with some more background information and examples. Believe it or not: It’s for free.
The PMS Playbook – ISO/TR 20416:2020
This guide is essential for implementing Post-Market Surveillance (PMS) for In Vitro Diagnostic (IVD) and medical device manufacturers. It is general in nature and does not supersede any EU regulations. However, Notified Bodies will anticipate that you adhere to its recommendations.
ISO 20916:2019 – Clinical performance studies
Provides detailed information on how to plan, design, conduct, record, and document premarket and postmarket IVD clinical performance studies.
World Health Organisation – PMS guidance
This document provides an overview of proactive and reactive procedures for post-market surveillance that manufacturers of IVDs will implement. The PMS guidance emphasizes reactive post-market surveillance through collecting and evaluating feedback, and any required actions to correct and prevent recurrence. It also provides an overview of the market surveillance activities that are the responsibility of National Regulatory Authorities.
Okay, so that’s it?
Sounds a bit disappointing, but read the ultimate PMS Guidance that I wrote. Both the MDR and the IVDR have the same surveillance principles. A reactive PMS system and the pro-active post-market performance follow-up activities. Based on my guidance, the IVDR text and the relevant guidance you can easily figure out the applicable route for you. In addition, I can recommend joining the videocourse Wizard that we created and that also covers the PMS system. In addition, I recommend to use our free templates in order to write:
- SOP Post-Market Surveillance – The overall structure is the same for IVDs.
- PMS Plan – The priniciples like trending and reporting are the same. Change the wording and the regulatory references.
- PSUR/PMS Report – Well, see above.
- PMCF-Plan – The content is nearly the same, change the wording and the references.
- PMCF-Report – Change the wording and call it PMPF-Report. I recommend to just keep it as a template and update the performance evaluation report directly.
