The MDR obliges the manufacturers of medical devices to carry out post-market surveillance (PMS) and thus to collect PMS data. This article is intended to help clarify which regulatory requirements manufacturers must observe when collecting this PMS data. In particular, it is intended to show whether manufacturers need to involve an ethics committee if the data is generated during routine use of the products.

1. PMS data: The question

This article was triggered by a discussion between a manufacturer of medical software and a notified body. Both disagreed on the need to comply with the Declaration of Helsinki and obtain an ethics vote when collecting PMS data. There was also disagreement as to whether this collection of data was already a clinical trial.

In this specific case, the manufacturer used data for post-market surveillance that accumulated during routine use of the product. Specifically: The manufacturer neither intervened in the treatment nor recorded additional data. Rather, he used the data that the medical device stored in its database when used as intended.

The main question to be answered is: "When does a manufacturer require an ethics vote when collecting PMS data, and when does this collection count as a clinical investigation?"

In order to answer these questions, it must be broken down into further sub-questions. Below you will find these sub-questions and the corresponding answers.

2. Relevance of PMS data

With the transition to the MDR, manufacturers are becoming more aware of the collection of PMS data. Notified bodies request the PMS plans and want to understand how the data is collected, evaluated and evaluated and how it is included in the clinical evaluation, among other things.

If manufacturers (erroneously) overestimate the regulatory hurdles for collecting PMS data, this may prevent them from using routine data. In doing so, they counteract the objective of the MDR to obtain reliable statements on the safety and performance of medical devices through post-market data.

If there is clarity about the regulatory requirements, manufacturers can avoid unnecessary regulatory risks (at "approval"). In addition, manufacturers and notified bodies were spared unnecessary and time-consuming discussions - and the ethics committees unnecessary inquiries.

3. Answers to the questions about collecting the PMS data Disclaimer & Acknowledgment

Lawyers from a German authority and the EU worked on this article, but do not want to be named. The descriptions in this article are "in progress", since the lawyers among themselves have not yet reached agreement on all points.

assumptions

The answers are based on the following assumptions:

  • The manufacturer collects data (or has it collected, e.g. by the operator or the user). He uses this data for post-market surveillance.
  • The data is generated "automatically" when the product is used as intended and routinely. And that regardless of whether they are required for post-market surveillance. This means that no additional data is collected for the PMS.
  • There are no additional procedures or procedures that put a strain on the patient.
  • The collected data can be assigned to the persons (patients).
Caution!

Note that all statements in this article are based on these assumptions.

summary

The diagram provides a brief overview of the questions and answers:

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