Information of safety can reduce risk now?

adir88

Starting to get Involved
#1
My question is simple: can information for safety now be used to reduce risk? It seems apparent from the relevant sections of MDR and ISO 14971 below, but would like to get a confirmation from this community as this is a significant change from MDD deviation.

ANNEX I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
CHAPTER I
GENERAL REQUIREMENTS
4. Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
(a) eliminate or reduce risks as far as possible through safe design and manufacture;
(b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and
(c) provide information for safety (warnings/precautions/contraindications) and, where appropriate, training to users.
ISO 14971:2019
Section 7.1 Risk control option analysis
NOTE 2 Risk control measures can reduce the severity of the harm or reduce the probability of occurrence of the harm, or both.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
My question is simple: can information for safety now be used to reduce risk? It seems apparent from the relevant sections of MDR and ISO 14971 below, but would like to get a confirmation from this community as this is a significant change from MDD deviation.
My understanding is similar to yours, but the ones who set the tone (in the current lack of official MDR guidance, harmonization list and annexes Z) are MDR-designated NBs.

What you call "MDD deviation" has always been in some dispute and subject to debate. Never a widely accepted and applauded gift to humanity.
 

Tidge

Quite Involved in Discussions
#3
My advice is to not rely on IFS as a mechanism (i.e. a risk control measure) to claim a risk reduction prior to performing a risk control options analysis and/or a risk benefit analysis. Most examples of what folks consider to be IFS are not shown to have any measure of effectiveness (i.e. lack objective evidence). I do believe that identification of specific IFS could improve risk acceptability in the context of an RCOA/RBA.

I can offer a few examples of "IFS-adjacent" implemented risk controls where I am comfortable claiming a risk reduction. My experience is primarily with Medical Electrical devices; YMMV on how much risk reduction you can claim (based on effectiveness of the risk control).
  1. Alarm Systems are PMD, even if they present "information" about an alarm status. User manuals are obligated to explain the alarm system, but an alarm system is intended to reduce risk. I use a "linear" approach to risk analysis: The Alarm System elements get identified as PMD (because they get tested and shown to reduce certain risks) and then the manual pages explaining the alarm system gets listed as IFS.
  2. Every user of the ME device gets specific training (provided by the manufacturer) that includes training elements targeted to specific risks. Training curricula can be implemented and the effectiveness of the training can be evaluated. Obviously this would be more effective if the device has been designed to only be used by trained users.
 

adir88

Starting to get Involved
#4
My understanding is similar to yours, but the ones who set the tone (in the current lack of official MDR guidance, harmonization list and annexes Z) are MDR-designated NBs.

What you call "MDD deviation" has always been in some dispute and subject to debate. Never a widely accepted and applauded gift to humanity.
Completely agree with you. Despite its controversial nature, our NB have always asked us to update to our risk management documentation because the likelihood post-RCM was reduced for certain items where only information for safety was used as a risk control measure. It will be good to move away from this.

Unrelated question: do you know if there will be any deviations in the harmonized ISO 14971:2019? The FDIS had the ZA annex which did not note any deviations to any clauses, but I understand this is likely to change given that the reason the harmonized version wasn't published in 2019 as there were comments that needed more time.
 
#5
My understanding is that you can and should user labeling to try to reduce risk, but to actually claim that occurrence level of a risk is reduced, you would have to prove it with say a Usability study. You would likely have to also have on-going training (not just a label on the package).
 

Chrisx

Involved In Discussions
#7
Frankly, this whole concept that information for safety never made any sense. Why do regulations require IFUs, if they don't do anything to reduce risk? Furthermore, this requirement in EN ISO 14971:2012 was in regards to any "Information for Safety", not just IFUs. That means, surgical technique guides, equipment manuals, on-site training, cadaver labs, etc. It's all information for safety. I think the authors of the MDR realized this made no sense, consequently the new regulation allows risk reduction thru information for safety.
 

Tidge

Quite Involved in Discussions
#8
Frankly, this whole concept that information for safety never made any sense. Why do regulations require IFUs, if they don't do anything to reduce risk? Furthermore, this requirement in EN ISO 14971:2012 was in regards to any "Information for Safety", not just IFUs. That means, surgical technique guides, equipment manuals, on-site training, cadaver labs, etc. It's all information for safety. I think the authors of the MDR realized this made no sense, consequently the new regulation allows risk reduction thru information for safety.
The reasoning behind forbidding IFS as a risk control that could reduce risk was explained to me as: "Disclosing (in a manual) that your device causes a certain type of harm doesn't make the device safer than if you don't disclose the information."

I agree that there hasn't been a particularly coherent approach to IFS. I think 60601-1-8 still refers to the presentation of "values of monitored variables" as 'information for safety', even though such presentation is almost certainly going be adjacent to, if not part of, the intended use/essential performance of the device. I feel like there are other examples (62304?) where the functional presentation of information is presented as "IFS" when it ought to be treated as PMD (subject to usability considerations of course). I'm not sure if this is still the case, but I seem to recall that there was at least one standard (either in the text or the informative material) that referred to "alarms" (not clarifying "alarm signals", nor "alarm systems") as "IFS".
 

adir88

Starting to get Involved
#9
Frankly, this whole concept that information for safety never made any sense. Why do regulations require IFUs, if they don't do anything to reduce risk? Furthermore, this requirement in EN ISO 14971:2012 was in regards to any "Information for Safety", not just IFUs. That means, surgical technique guides, equipment manuals, on-site training, cadaver labs, etc. It's all information for safety. I think the authors of the MDR realized this made no sense, consequently the new regulation allows risk reduction thru information for safety.
I guess it comes down to whether or not it can be verified that the information for safety in an IFU etc. is actually effective in reducing risk. In most cases, I think the answer is NO unless the specific information was assessed in usability evaluation and there was objective evidence that demonstrates that information led to risk reduction.
 

adir88

Starting to get Involved
#10
The reasoning behind forbidding IFS as a risk control that could reduce risk was explained to me as: "Disclosing (in a manual) that your device causes a certain type of harm doesn't make the device safer than if you don't disclose the information."

I agree that there hasn't been a particularly coherent approach to IFS. I think 60601-1-8 still refers to the presentation of "values of monitored variables" as 'information for safety', even though such presentation is almost certainly going be adjacent to, if not part of, the intended use/essential performance of the device. I feel like there are other examples (62304?) where the functional presentation of information is presented as "IFS" when it ought to be treated as PMD (subject to usability considerations of course). I'm not sure if this is still the case, but I seem to recall that there was at least one standard (either in the text or the informative material) that referred to "alarms" (not clarifying "alarm signals", nor "alarm systems") as "IFS".
Is there a definition of "information for safety" in any standards or guides? IFS is commonly considered to be the same as "accompanying documentation", but TR/ISO 4971 includes examples that not only include contraindications and instructions for use in accompanying documentation, but also warning labels on the device itself and training.

I completely agree with you in that there hasn't been a consistent approach from various standards committees to what is IFS which has definitely contributed to the confusion.
 
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