Labelling and the harmonized EN ISO 14971:2012

[Mark Meer]

So I'm in the process of updating our risk file as per the harmonized EN ISO 14971:2012.

My biggest difficulty trying to justify risk-levels if instructions provided to the user (labelling) cannot be used as a control measure.

In our previous risk-analyses, we depended exclusively on warnings to mitigate risk from:
- contraindications
- deliberate misuse
- using in dangerous environments
- use when obviously damaged (or attempts to fix/repair)

In these cases, I'm as a loss for what else can be done to reduce risk other than warn the user not to do them! If warnings are excluded from risk control, then these are (according to our risk management process) unacceptable risks.

Curious if anyone can share their experiences in updating their risk-analyses, or dealing with NBs, following to exclude labelling/warnings from risk control.

 

[esalsan]

Hi Mark,

Without knowing what type of device you are dealing with or some examples it is very difficult to help. However, section 6.2 of the standard gives you some clues for risk control (in order of preference):
1. the device should be designed to be safe
2. implemente protective measures in the device
3. information for safety

It sounds like you started the risk analysis at a late stage and that the design of your device may need to change, but I don't really know.

If none of the above options for risk control are practicable (you would struggle to defend the practicability to your notified body) you, as a manufacturer, will have to conduct a risk/benefit analysis to determine whether the benefits of your device (to the patient) outweighs the residual risks. E.g. defibrillators pose a risk of electrical shock that cannot be removed... but without it, the potential patient will die.

Hope it helps.

 

[Mark Meer]

Without knowing what type of device you are dealing with or some examples it is very difficult to help. However, section 6.2 of the standard gives you some clues for risk control (in order of preference):
1. the device should be designed to be safe
2. implemente protective measures in the device
3. information for safety

There appears to be some confusion on the intended topic...

What I'm referring to is the harmonized version of 14971 (EN ISO 14971:2012), in which (as I understand from Annex ZA) point 3 above is no longer an acceptable control in terms of presumed conformity to the European regulations.

I'm curious how others have handled this, and how it affects previous risk evaluations for hazards that previously depended on labelling to mitigate risk.

I'm particularly interested in those hazards whose risk cannot be controlled in any other way (e.g. contraindications, misuse..etc.). Must a risk/benefit analysis for all these types of hazards now become an expected/necessary activity?

NOTE: I'm working off a draft version that only notes differences in the EN version. ...so if I'm mistaken with regards to the expectations of the final harmonized version, please let me know...

 

[Ronen E]

NOTE: I'm working off a draft version that only notes differences in the EN version. ...so if I'm mistaken with regards to the expectations of the final harmonized version, please let me know...

Mark, the only material differences between ISO 14971:2007 and (the finalized & harmonized) EN ISO 14971:2012 are in the Z annexes.

7. Information of the users influencing the residual risk:
a) The residual risk is in 2.15 and in 6.4 of ISO 14971 defined as the risk remaining after application of the risk control measures. 6.2 of ISO 14971 regards "information for safety" to be a control option.
b) However, the last indent of Section 2 of Annex I to Directive 93/42/EEC says that users shall be informed about the residual risks. This indicates that, according to Annex I to Directive 93/42/EEC and contrary to the concept of the standard, the information given to the users does not reduce the (residual) risk any further.
c) Accordingly, manufacturers shall not attribute any additional risk reduction to the information given to the users.

 

[Mark Meer]

c) Accordingly, manufacturers shall not attribute any additional risk reduction to the information given to the users.

Thanks for confirming this in the final version Ronen. This is the specific item in the harmonized standard that's irking me.

 

[MIREGMGR]

Must a risk/benefit analysis for all these types of hazards now become an expected/necessary activity?

My understanding is yes.

Such a risk/benefit analysis needn't be a huge exercise, if the analyzed situation is well understood and not novel.

If on the other hand it is novel, then certainly it makes sense from both the design and the auditing perspective to have a comprehensive analysis, so as to demonstrate that in fact the situation is well understood and not just being glossed over.

 

[pkost]

Thanks for confirming this in the final version Ronen. This is the specific item in the harmonized standard that's irking me.

Although this clause initially caused some consternation, I'm not sure why - labels cannot be used to reduce the level of risk (this is entirely reasonable - how often to users truely read an IFU?). As a consequence look to using other risk reduction methods

If you are unable to reduce the risk using other methods to an acceptable level, conduct a risk benefit analysis.

For existing products where you have previously had a risk management file that includes using labels as a risk mitigation step, review the content, indicate that your risk level has increased, but balance this against your post market surveillance activities to demonstrate the safety and efficacy of the device

 

[Greenfield]

I know this is an old thread and the subject has been beaten to death (if not here, everywhere else) but I'm looking for a bit of clarification, hoping my interpretation is correct:

I interpret Issue #7 in the ZA and ZC annexes such that you cannot reduce "residual" risk any further by adding a statement of this residual risk to instructions (see item 7b and 7c in Annex ZA and ZC). Again, I interpret this as saying I might be able to reduce initial risk by providing labeling (and IFU) but identifying the residual risk in the labeling (and/or IFU) cannot provide additional risk reduction.

We're not the "manufacturer" but we do help out and perform some limited assessments typically for low and medium risk devices. We usually have little to no input into labels and IFU... so it hasn't been a real issue yet. But it'd be nice to know how everyone else is interpreting and applying these annexes.

Comments are appreciated.

Thanks

 

[Marcelo]

Yes, this is the correct interpretation of the deviation. This was also corrected in the text of the MDR (Annex I, Chapter I, item 4).

Please note that a lot of people (including NBs) still do not understand it this way.

 

[subbash]

Dear @Marcelo Antunes,

Can we cite the "information in Instruction for use" as a risk control measure...?