MDR - difference between configurable device and device with accessories

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:

• EU MDR Article 2 – Definitions https://advisera.com/13485academy/mdr/definitions/
• EU MDR Article 22 – Systems and procedure packs https://advisera.com/13485academy/mdr/systems-and-procedure-packs/
• EU MDR Annex 2 – Technical documentation https://advisera.com/13485academy/mdr/technical-documentation/
• EU MDR Annex 3 – Technical documentation on post-market surveillance https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/