Requirements for MDR Article 22 Systems

#1
Can any kindly confirm my understanding of a device system, given the scenario:

Commonly used Device A , Device B , Device C and simple disinfectant products are used together within a medical procedure which consists of two (2) medical processes within it. All devices are single-use, disposable devices (non-electrical).

- Device A is a non-invasive medical device and alone performs Medical Process #1 to begin the Medical Procedure.
- Device B is a surgically invasive medical device and enters the body to start Medical Process #2
- Device C is a non-contacting IVD that is combined with Device B after it enters the body and completes Medical Process #2 , later used during an Analytical Testing.

1. Device B and C are compatible for use together and interoperable in their combination and therefore are a system according to MDR Art. 22, even if sold separately.
2. All devices and products are compatible for use together, and if packed together would be a procedure pack containing a system.
3. Device B and C were not a system previously because MDD Art. 12 does not allow IVD devices in a system.
4. Device B and C must be certified under MDR as a system, or be able to identify all systems they each are interoperable and compatible for use within, and any restrictions. (Can MDR Device B identify IVDD Device C until IVDR approval?)

5. System B/C would not have to identify restricted combinations in IFU, as manufacturer only intends for them to be used together.
6. System B/C can be Annex X Type Examination certified and undergo Annex XI Product Conformity Verification Part A Production QA. (are there benefits to this? I see only one technical file is reviewed per type certificate... is the system a single 'type'??)
7. System B/C only requires a single Basic UDI-DI.
8. System B/C devices sold separately do not need UDI carrier on their unit level labels. (single use, disposable)
9. Would a Notified Body have to be MDR and IVDR designated to review System B/C?

Thanks
 
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dgrainger

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#2
Article 22 applies if you combine the products and place them on the market as a system/procedure pack.
Use isn't the determining factor.
 
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