Annex I Chapter I 3(a) clause states:
I've noticed in several articles online that emphasize "each device" in this requirement.
Is this a new MDR requirement? In our company we have risk management plans for product families (each family containing a different "model" of the device), so might have an impact to this approach under the MDR. Having said this, the Annex ZD in draft ISO 14971:20xx for this clause points to Subclause 4.4 of ISO 14971:20xx with a note "covered in respect of the process requirements". I understand there were comments on Z annexes which is why they weren't included in the 2019 publication, so this could change in the upcoming amendment.
So, my questions are:
establish and document a risk management plan for each device
Is this a new MDR requirement? In our company we have risk management plans for product families (each family containing a different "model" of the device), so might have an impact to this approach under the MDR. Having said this, the Annex ZD in draft ISO 14971:20xx for this clause points to Subclause 4.4 of ISO 14971:20xx with a note "covered in respect of the process requirements". I understand there were comments on Z annexes which is why they weren't included in the 2019 publication, so this could change in the upcoming amendment.
So, my questions are:
1. Is this a new MDR requirement, and if so, what approaches are you taking as part of MDR transition?
2. Can the product family be considered as "a device" given that they share the same intended use etc. including use specification?