New EU Medical Device Regulation & Reconciling with EN ISO 14971

blah01

Involved In Discussions
#31
Just an FYI on the issue of economic consideration, the current MDD does state that “...any reference to ‘minimizing’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety...”...
Marecelo had replied stating...
Point is, it's impossible not consider economic considerations. If you would treat every little imaginable possibility of a hazard with the best safety solution, you could have:
- a device which is not physically possible to exist
- a device so expensive that no one would be able to use it
- more bizarre options
Actual thread: https://elsmar.com/Forums/showthread.php?t=69845&page=3

The poor interpretation of EN ISO 14971:2012 causes the confusion, but I've been assuming economic consideration can be factored in; mind you we're a low risk product and don't get audited so I haven't had to debate this with our NB.
 
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Marcelo

Inactive Registered Visitor
#32
Do you think we can use this change in the future MDR to argue that AFAP was never intended in current MDR and the above consensus has been effectively accepted as evidenced by the new MDR?

The main problem right now is that:
1 - The interpretation of the future MDR is right now is only this- an interpretation
2 - You are not complying with the MDR, but with the old directives, so any acceptance will depend on your NB accepting the future requirements

Also,
If the new MDR 'fixes' the ASAP, then why does EN13485:2016 appear to endorse ISO14971:2012’s Annex ZA seven deviations in compliance with 93/42/EEC MDD, as if unaware that the new MDD 2017 has removed the reason for these deviations?

Or can we expect a new EN13485:2020 when the new MDR takes effect?
EN13485:2016 was created before the MDR was published, all/many standards will need to be revised.

Quote:
In Reply to Parent Post by michael Cejnar View Post

is there any way we mere mortals can know this - whether the Consensus has "Interim NBMed status" as per Northbridge or it's 'rejected' by someone?

I don't remember Marcelo's exact explanation, I just vaguely remember that he commented on that. I have no special search powers and you're just as qualified as me to track down that post. Perhaps Marcelo would be able comment on it again, here (my thanks in advance).
The document was created by NB-MED (which is an"association of NBs, not an official EU document) to try and solve the problem with EN 14971, however, it has never been endorsed by the EU Commission, in part because the deviations from 14971 came from the EU Commission. Unfortunately, I don't know any "formal" way to show it's no endorsed besides there being no endorsement.

"The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio."

The regulation expects me to do this for all risks.
If I have a look at the benefit-risk ratio (B/R) during risk mitigation, there are 3 ways how it may behave:
1. The ratio stays the same: B1/R1=B2/R2
2. The ratio increases: B1/R1<B2/R2
3. The ratio decreases: B1/R1>B2/R2 ("adversely affecting the benefit-risk ratio")
Obviously there's still no consensus on this, but I would take care with your comments. The benefit/risk ratio only makes sense in evaluating the device (aggregate) risk, not every individual risk.

One example of in interpretation (which would be in line with at least the MEDDED on Clinical Evaluation:


If your device (aggregate) benefit/risk profile is evaluated by using the following principles (from the FDA Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions. and also cited in the Clinical evaluation MEDDEV):

Benefit Assessments evaluated by evaluating:
Type of benefit(s)
Magnitude of benefit(s)
Likelihood of patients experiencing one or more benefits
Duration of effects
Patient perspective on benefit
Benefit factors for healthcare professionals or caregivers
Medical necessity

Risk Assessments evaluated by evaluating:
Medical device-related deaths and serious injuries
Medical device-related non- serious adverse events
Medical device-related events without reported harm
Likelihood of Risk
Distribution of Nonconforming Devices
Duration of the exposure to the population
What are the consequences of a false positive?
What are the consequences of a false negative?
Risk from false-positive or false- negative results for diagnostics
Patient tolerance of risk
Risk Factors for healthcare professionals or caregivers

Other factors as in the potential decisions based on the Benefit-Risk Assessment Outcome worksheet

Then, this evaluation would be the aggregate benefit/risk profile evaluation. Note that this do not focus individual risks. So, the statement:

"The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio."

Would mean that, without adversely affecting the the results of this aggregate benefit/risk evaluation.
 

Ronen E

Problem Solver
Staff member
Moderator
#33
Just an FYI on the issue of economic consideration, the current MDD does state that “...any reference to ‘minimizing’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety...”...
This is a well-known clause; unfortunately it's part of the non-binding part (preamble) of the MDD, and not a part of any MDD Article / Annex.

I've argued many times in the past that this clause demonstartes that that certain EN ISO 14971:2012 deviation goes against the MDD's intent. Apparently the EU commission cares less about the original intent than about current politics. :(
 

L_O_B

Involved In Discussions
#34
The benefit/risk ratio only makes sense in evaluating the device (aggregate) risk, not every individual risk.
That is the problem I tried to point at.

Would mean that, without adversely affecting the the results of this aggregate benefit/risk evaluation.
I also tried to explain this:
The justification for not implementing further risk mitigation measures is, that all further measures you can think of decrease the overall benefit-risk-ratio.
So far so good. But how do you justify not to implement a method without determining its isolated impact on this overall benefit-risk-ratio?
 

michael Cejnar

Involved In Discussions
#35
I have a humble suggestion for this thread.

Now that the new MDR has 'Entered into force' on 21 May 2017 (fully applicable 26 May 2020), before the regulatory industry again unhelpfully interprets General ER4 of this MDR to mean ALAP, may I suggest we, the industry, strike first and advocate for replacement of acronym ALAP with a new 'ALAJA', or 'As Low As Judged Acceptable".

This reason comes from the most logical interpretation of the MDR as follows (I insert implied clarifying wording in brackets):

MDR 2017
Annex I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
CHAPTER I - GENERAL REQUIREMENTS
Item 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 (MC: to arrive at acceptable residual risk for each hazard according to state of the art), manufacturers shall, in the following order of priority:

(a) eliminate or reduce risks as far as possible(MC:to achieve judged acceptable risk) through safe design and manufacture;
(b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated (or reduced to acceptable levels by design and manufacture); and
(c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users (MC: as the last order 'solution' in managing risk to lower it to acceptable risk).
I believe 'ALAJA', or 'As Low As Judged Acceptable" is the clear meaning of the new MDR.
It means:
1. Reducing risks only to acceptable levels, not ALAP - but according to State of the Art - fair enough.
2. Requires risk be reduced to this acceptable level, preferentially as far as possible by design & manufacture - fair enough.
3. Includes Warnings and Training as 'solutions', albeit last in order, for reducing risk to acceptable levels - again fair enough.

Any thoughts?

Since NB's audit focus seems to be unofficially but clearly influenced by new Regulations, it would make sense to push this 'new understanding' in audits even to MDD.
 
Last edited:

Chrisx

Involved In Discussions
#36
We had a further discussion here at work on EN ISO 14971:2012.

Deviation #2 states:

2. Discretionary power of manufacturers as to the acceptability of risks:
a) ISO 14971 seems to imply that manufacturers have the freedom to decide upon the threshold for risk acceptability and that only non-acceptable risks have to be integrated into the overall risk-benefit analysis.
b) However, Sections 1 and 2 of Annex I to Directive 93/42/EEC require that all risks have to be reduced as far as possible and that all risks combined, regardless of any "acceptability" assessment, need to be balanced, together with all other risks, against the benefit of the device.
c) Accordingly, the manufacturer may not apply any criteria of risk acceptability prior to applying Sections 1 and 2 of Annex I to Directive 93/42/EEC.

To our engineering staff, deviation #2 seemed to imply to them that you cannot have risk acceptability criteria in the risk management plan. The risk acceptability criteria would have to be established after all the risks have been evaluated. However, I did not think this was the case. I think the risk acceptability criteria (e.g. matrix), is required in the plan by ISO 14971. However, it needs to be clear that risk acceptability means acceptable risk/benefit. Also, regardless of risk/benefit, actions have to be taken to further reduce the risk as far as possible. Am I correct, that risk/benefit acceptablity criteria need to be in established in advance in the risk management plan, prior to risk evaluation?

Thanks!
 

Ronen E

Problem Solver
Staff member
Moderator
#37
We had a further discussion here at work on EN ISO 14971:2012.

Deviation #2 states:

2. Discretionary power of manufacturers as to the acceptability of risks:
a) ISO 14971 seems to imply that manufacturers have the freedom to decide upon the threshold for risk acceptability and that only non-acceptable risks have to be integrated into the overall risk-benefit analysis.
b) However, Sections 1 and 2 of Annex I to Directive 93/42/EEC require that all risks have to be reduced as far as possible and that all risks combined, regardless of any "acceptability" assessment, need to be balanced, together with all other risks, against the benefit of the device.
c) Accordingly, the manufacturer may not apply any criteria of risk acceptability prior to applying Sections 1 and 2 of Annex I to Directive 93/42/EEC.

To our engineering staff, deviation #2 seemed to imply to them that you cannot have risk acceptability criteria in the risk management plan. The risk acceptability criteria would have to be established after all the risks have been evaluated. However, I did not think this was the case. I think the risk acceptability criteria (e.g. matrix), is required in the plan by ISO 14971. However, it needs to be clear that risk acceptability means acceptable risk/benefit. Also, regardless of risk/benefit, actions have to be taken to further reduce the risk as far as possible. Am I correct, that risk/benefit acceptablity criteria need to be in established in advance in the risk management plan, prior to risk evaluation?

Thanks!
Technically you are both correct. The question is what are you trying to achieve. When considering EN ISO 14971:2012, it is a means to an end - achieving presumption of conformity (with the MDD's ERs). Otherwise, just use ISO 14971:2007 and ignore the deviations.

When it comes to MDD ER compliance, what the deviations say is that compliance with the normative part of EN ISO 14971:2012 is not enough, and that the manufacturer needs to observe to MDD directly. The question is whether you accept that verdict or not. Even if you do, it's not that simple because the MDD is badly worded in that it's very open to conflicting interpretations.
 

michael Cejnar

Involved In Discussions
#38
Hi Ronen E
It has been nearly two years.
BTW, BSI NB allowed me to grandfather all prior Risk Management with ALARP, provided I went AFAP going forward - a fair deal.

I am now changing my SOPs for MDR.

Have to decide -
1. Do we need to add back to the Risk Management SOP, defined acceptance criteria for the 'judging as acceptable" in the MDR text:
"Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable." (notwithstanding the subsequent 'eliminate or reduce risks as far as possible through safe design", which

2. Do I reference ISO14971:2012 Annex ZA/B in my SOP, or not, since it caters to obsolete MDD ER's, and if, I suspect, not, can I reconcile the ISO14971 with the more aligned MDR?

==============
For reference:
MDR
“Annex I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
CHAPTER I
GENERAL REQUIREMENTS
Item 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 [MC:to achieve risk judged acceptable] 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/contra-indications) and, where appropriate, training to users.
 
T

tox472

#39
Hi all, did you have a look at the draft of new ISO 14971? The annex related to GSPR indicates that RM addresses all GSPR for safety.
My understanding of risk acceptability is that:
-Each manufacturer shall define its risk management politics. This is not new, but maybe not implemented with the purpose of using risk analysis as the backbone of MD lifecycle.
-MDR requires each risk to be balanced against its related benefit and that overall risk acceptability shall include combined risks. Not new either, as, in my opinion this was the debate for harmonization of ISO 14971 in Europe.
I think the main change is that it is not possible to grandfather historic approaches and, that, unfortunately for us, NBs have not enough pointed out the coming requirements during third party audits.
I hope it helps!
Gaëlle
 

michael Cejnar

Involved In Discussions
#40
Thanks Gaëlle
Didn't know about the new ISO14971 - found a useful commentary: A Look At The ISO 14971 And ISO TR 24971 Updates
Key is that ISO will not change the Risk Management Process (good), more focus on defining benefits and they will move out the informative Annexes into the TR 24971 so they can be changed more frequently. They will also insert a clause and renumber all clauses by +1 (!?!!).
There is no harmonization with EU and CEN will need to redraft it's EN version to align with MDR - so uncertainty in EU will continue.

Hmm, not promising.
Seems that interpretations will continue to be made up by NBs.
I think I will notify my NB of my intention to define acceptable risk for ALAJA and see what they say.
 
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