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Case: Missed mixed status devices in a system

Incorporated IVD

A multi-component device is intended to be used surgically invasive, where a specific intervention can be performed via a minimally invasive technique. During this operation, a sample can be taken and stored in a container for transfer to the lab. Sampling is optional, it is not the main objective of this intervention. When submitting the documentation of this device to the notified body, the manufacturer got immediate feedback: the container should be considered a specimen receptacle and should be certified as an IVD. As this happened after the date of application of the IVDR, the vial should be considered an IVD of Class A. This brought the certification process at the notified body to an abrupt standstill, because even a Class A technical file and quality management system cannot be set up overnight.

Regulatory context

MDR Article 1(7) addresses the situation when a medical device incorporates an IVD. In that situation, the whole device must comply with the MDR, but the IVD must comply with the IVDR. Even for highly experienced regulatory experts in medical devices, creating ‘simple’ Class A technical documentation would require time and attention to get this right. Although the notified body would not assess the technical documentation, they said they wanted to verify the compatibility of the two sets of documentation. Therefore, this company did not want to risk its certification process by creating technical documentation they did not feel comfortable with.

Switching from a single, multi-component device to a system

The notified body gave the company three weeks to respond before they would stop the certification process. The manufacturer reached out to me for help. A quick look at the technical documentation learned that the container was not addressed in detail in the technical documentation. It mentioned this component in the device description and some other paragraphs with its particular details, that were quite separate from the rest of the documentation. Initially, the company wanted to know if they could just remove the container from the device, which would no longer have sampling collection as an optional step in the use of the device. The company told me that the user would probably use another container if they wanted to collect samples. As a result, we decided to start removing the container from the technical documentation.

While doing that I also suggested they could look for an alternative container that had been CE-marked as an IVD and was intended for the type of samples their device would collect. Indeed it was possible to obtain such a device, so while their device was being assessed by the notified body they were setting up the statement and relevant documentation to ensure they can supply that CE-marked specimen receptacle with their device in a procedure pack under Article 22. Their device has its instructions for use, and the procedure pack only sets out how to use the container for sample collection. This procedure pack will in a later stage also be listed in the appropriate section in EUDAMED. At this moment the device is still under review by the notified body, but the first round of feedback did not address the container.

Lessons learned

The main lesson this company learned is that they should have paid more attention to the product status of each component in their device. If they had done this much earlier, it would have saved them some panic and overtime.

Check your multi-component devices

If you place multi-component devices on the EU market, you should take care you check all components for any specific requirements. An IVD component could be identified easily with this example in mind, but how about devices that incorporate software? Or a device containing some components that are used invasively, and others are not? I would recommend having someone like me check your multi-component devices well before a notified body does that. You just don’t want to be in a situation where you need to take important decisions under great pressure.

Help from Boumans Regulatory Consulting: