Is your PMS data analysis effective and appropriate?

There’s good news to share! Dr. Jennifer Dean, Regulatory Affairs Expert at Metecon, is happy to let you know that the results of her master’s thesis in Regulatory Affairs were published as a focus article in the Journal of Medical Device Regulation (JMDR) in May, 2022. This paper is a result of a collaboration with Prof. Dr. Folker Spitzenberger at the University of Applied Sciences Lübeck (Lübeck, Germany) and Mr. Patrick Meisel at implantcast GmbH(Buxtehude, Germany); they also would like to acknowledge the input from a notified body regarding their work.

Today, Jen is delighted to demonstrate how you can use the results of her master's thesis to enhance your Post-Market Surveillance (PMS) activities.

Which triggers for which type of data?

The details of our results are described in the paper, so today I wanted to write more about how you can use these results as part of your post-market surveillance (PMS) activities for medical devices. This paper is about choosing the right triggers for your data when you implement trend detection tools as part of PMS. Trend detection tools can be used in PMS as part of the data analysis (data assessment). The background here is that your triggers should fit to the type of data you have. If this is not done, then you may find that the triggers will not be able to initiate a response at the right time as intended. At the other extreme, you may find that the triggers may be set in such a way that they respond too quickly and can initiate unnecessary responses for the medical device manufacturer. Therefore, it is important to understand how the triggers will function on the actual data for your medical devices.

Your trend detection tools: Appropriate and effective for your medical device?

One of the reasons that this paper may be relevant to you is that it can help readers answer the difficult question of whether your trend detection tools are likely to be appropriate and effective for your medical device. The concept of appropriate and effective methods and processes for assessing the collected PMS data is set in Annex III of Regulation (EU) 2017/745 (MDR) and Annex III of Regulation (EU) 2017/746 (IVDR). In this particular case we looked at this issue for trend detection tools. However, trend detection tools can only be applied to certain types of PMS data, such as quantitative data with an established baseline. For other types of PMS data (especially qualitative PMS data), this question is still a challenge for medical device manufacturers to address. For this reason, I would like to provide you with some ideas on how to evaluate your PMS data analysis.

Tips for evaluating your PMS data analysis

One of the indications that the methods or processes selected for your PMS data analysis may not be particularly effective or appropriate is when it is unclear how the analyzed data relates to one of your PMS aims (for example, to improve risk management or update the clinical evaluation). This problem usually becomes apparent when it is time to prepare the first Periodic Safety Update Reports (PSURs) according to Article 86 of the MDR (or Article 81 of the IVDR) and /or the first PMS Reports (Article 85 MDR; Article 80 IVDR). As part of the PSUR or PMS Report, it is required to include the results and conclusions of the analyzed PMS data where these conclusions address the stated PMS aims and required further actions. If your data analysis does not deliver the information that you need for the results and conclusions in your PSUR / PMS Report or cannot help you determine whether further actions are necessary, then the planned PMS activities need to be re-evaluated. The problem can be either that irrelevant PMS data is collected or that the PMS data is not analyzed in an appropriate or effective way.

How does PMS perform in your company?

PMS under the MDR / IVDR can be time and cost intensive. Therefore, it makes sense to ensure that the resources invested in PMS are used effectively. Now that PMS according to the MDR has been required for almost a year now, it is a good time to take a critical look at how PMS performs in your company. It is often helpful to consult with external experts who can provide an outside perspective on streamlining PMS activities to ensure a close alignment between your PMS aims, PMS data collection and analysis, evaluation of PMS data, identification of further measures and PMS reporting requirements. The goal here is to have an appropriate level of post-market surveillance carried out in an effective manner.

Our PMS team at Metecon can help you with this external viewpoint whether or not your PMS activities include trend detection tools. In addition, the JMDR publication shows that assessing PMS under the MDR / IVDR can be a challenge and we want to share our experience with you. Our team is looking forward to hearing from you!

Best regards,

Dr. Jennifer Dean
Expert Regulatory Affairs
+49 621 123469-050

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