Labeling can be used as a risk control. The MDR and IVDR state that in GSPRs. BUT and there is always a but, you must verify the effectiveness of the risk control. What does that mean?
Simply you should have a Usability Validation of your risk control in your IFU. That means you must have objective evidence from a Design (Usability) Validation activity that proves your risk reduction down to the level you claim. That means if you claim a severity or probability reduction you must have the objective evidence of that claim. Most often severity can only be reduced through a design change. Unless you have evidence for any risk control you cannot claim risk reduction.
Hopefully this exlanation will help. I did point to MDR and IVDR, but this process I described works for all regulatory systems.
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Member, ISO TC 210 JWG1
MEd, CQA, RAC, BSc, CQE, ASQ
Overland Park KS
United States
elb@edwinbillsconsultant.comPrincipal ConsultantMEd, CQA, RAC, BSc, CQE, ASQMEd, CQA, RAC, BSc, CQE, ASQMEd, CQA, RAC, BSc, CQE, ASQ
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Original Message:
Sent: 23-Jun-2022 09:57
From: Anonymous Member
Subject: Labeling and Risk Control
This message was posted by a user wishing to remain anonymous
Which of the following is correct per ISO 14971:2019? Or some combination thereof?
1) Labeling cannot be used as a risk control method which reduces either severity or probability.
2) Labeling can be used as a risk control method which reduces either severity or probability.
3) Labeling can be used as a risk control method but can only reduce probability, not severity.
4) Labeling can be used as a risk control method but given it is a low level of control it cannot be the sole control method to address an identified hazard.