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MDR - difference between configurable device and device with accessories

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Guest user Created:   May 19, 2021 Last commented:   May 20, 2021

MDR - difference between configurable device and device with accessories

I am working on the documents to comply with the MDR for our products. I'm a bit confused about what applies to my case: We send a kit with a main device and some parts that can optionally be attached to the main device for certain patient groups to fulfill the intended purpose of the main device. So some patients will need the parts on the device, others not. Can we call this a configurable device or is this a device with accessories? And if this is a configurable device, when would this have been accessories? If I understand it correctly from the MDR, we need a separate Declaration of Conformity and Technical file for accessories, but not for components of a configurable device, right?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić May 20, 2021

If I understand it correctly, your device will be a system. According to the Definitions in the MDR system (point 10) is a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.

The question here is: are parts separately certified as medical devices?

For systems that consist of parts that are medical devices, according to Article 22, you need to prepare the statement that will have the following information:

  • verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manu­ lecturer's instructions and have carried out their activities in accordance with those instructions
  • packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together
  • the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification, and validation.

However, if your parts are not a medical device, that it needs to be certified as a system separately. In that case, you need the involvement of the Notify body, you need to prepare applicable technical documentation according to Annex 2 and 3 of the MDR, and in that case, you will put a CE mark on that system.

For more information, see:

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May 19, 2021

May 20, 2021