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MDR requirement: Risk Management Plan for "each device"

adir88

Involved In Discussions
#1
Annex I Chapter I 3(a) clause states:
establish and document a risk management plan for each device
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:
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?​
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
I think that no matter what responses you will get here, the only one that will carry any weight in this matter is your specific NB's one. That's where I'd go to.
 

Tidge

Trusted Information Resource
#3
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?​
I agree that you will be at the mercy of your NB. My impression is that there are lower-hanging fruit for NB's to pick during at this time of transition rather than reaching for this specific issue, provided that a "family's" Risk Management Plan appropriately covers all members of the family. If your "wide" RM Plan clearly describes the products covered, and it has the necessary input/output mechanisms to other systems (e.g. CAPA, Complaints) I wouldn't spend effort trying to remediate those files simply as a preventative measure to possibly satisfy an external audit. If an NB auditor takes issue with your risk file, it is far more likely that it will be for some element which you haven't anticipated.

Writing only for myself, as an intellectual exercise: I would be interested to see how your file handles complaints/issues/CA/design changes for a single member of the family with respect to all the other members of the family. For example, do some members of the family get more complaints, and is the risk profile really the same for all members of the family? Are there different user groups and risk controls for different members of the family? Personally I would consider this to something of a "deep dive", but I can imagine getting to similar questions via something a simple as a review of complaints.
 

adir88

Involved In Discussions
#4
I agree that you will be at the mercy of your NB. My impression is that there are lower-hanging fruit for NB's to pick during at this time of transition rather than reaching for this specific issue, provided that a "family's" Risk Management Plan appropriately covers all members of the family. If your "wide" RM Plan clearly describes the products covered, and it has the necessary input/output mechanisms to other systems (e.g. CAPA, Complaints) I wouldn't spend effort trying to remediate those files simply as a preventative measure to possibly satisfy an external audit. If an NB auditor takes issue with your risk file, it is far more likely that it will be for some element which you haven't anticipated.

Writing only for myself, as an intellectual exercise: I would be interested to see how your file handles complaints/issues/CA/design changes for a single member of the family with respect to all the other members of the family. For example, do some members of the family get more complaints, and is the risk profile really the same for all members of the family? Are there different user groups and risk controls for different members of the family? Personally I would consider this to something of a "deep dive", but I can imagine getting to similar questions via something a simple as a review of complaints.
The individual products within each family do not have any differences with respect to user groups and risk controls which makes review of the risk management file due to complaints etc. very simple. I agree keeping the family plans as is in our current system unless requested by our NB.

Many thanks!
 

Ronen E

Problem Solver
Staff member
Moderator
#5
The individual products within each family do not have any differences with respect to user groups and risk controls which makes review of the risk management file due to complaints etc. very simple. I agree keeping the family plans as is in our current system unless requested by our NB.

Many thanks!
Probably better to be proactive and present the question to the NB upfront, rather than wait to audit day and risk a NC.
 
#6
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:
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?​
A product family as you described can utilize the same RM Plan and Report
 
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