Retrospective Application of EN 60601-1:2006 - Harmonized Standards

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M

MIREGMGR

#2
Re: Retrospective Application of EN 60601-1:2006

I'd like to have a recognized guidance for objective balancing of, and decision making regarding:

1. The economic considerations for the maker.
2. The differences in benefits and risks for users/patients/society.
3. The availability-economics issues for users/patients/society due to costs that must be recovered and the consequent impact of cost-of-care on care availability and total care delivered.

Such a guidance seemingly would have to quantity the value of health and life, among other things, and thus might be societally specific.

I don't think any agreement on the question posed by the presented analysis will be possible until we can work through the how-to-decide issues.
 

Peter Selvey

Staff member
Super Moderator
#3
Re: Retrospective Application of EN 60601-1:2006

Hi MIREGMGR,

An interesting discussion, but perhaps a separate issue. The issue I'm raising here is one of legal interpretation, not comment on the impact to society. My personal opinion is retrospective application is reasonable, but on a longer time frame of maybe 7-10 years. In other words, allow the manufacturer to use harmonized standards applicable at the "time of design", but with a time limit of not more than 10 years.

But that's beside the point. The basic question is what does the current law require in terms of retrospective application.
 
#4
Re: Retrospective Application of EN 60601-1:2006

An interesting and informative article Peter. I'm still digesting it so will maybe add something later.

One small point - the paragraph that starts
Since the principles of free movement, essential requirements the presumption of conformity all apply to the device
doesn't read very clearly.
 
M

MIREGMGR

#5
Re: Retrospective Application of EN 60601-1:2006

Hi MIREGMGR,

An interesting discussion, but perhaps a separate issue. The issue I'm raising here is one of legal interpretation, not comment on the impact to society. My personal opinion is retrospective application is reasonable, but on a longer time frame of maybe 7-10 years. In other words, allow the manufacturer to use harmonized standards applicable at the "time of design", but with a time limit of not more than 10 years.

But that's beside the point. The basic question is what does the current law require in terms of retrospective application.
My expectation is that whatever other stakeholders (major device makers, UL, other NRTLs, other regulatory-jurisdiction authorities) may opine, US FDA will make their own decision in a particular instance, and that will be precedent in the US and will be determinative until/unless someone gets a Federal District to rule otherwise...which would be expensive, difficult, uncertain and time consuming.

If I were preparing a submission to FDA that asked for or depended on such an FDA decision, I'd very much want and need the guidance that I outlined as the basis for the decision-case I would prepare.

What we decide here interpretively will be irrelevant in the US once the FDA decides. As with almost all US legal judgements, the decision they will make will be shaped by the case presented to them.
 

pkost

Trusted Information Resource
#6
Re: Retrospective Application of EN 60601-1:2006

Each standard should be viewed on a case by case basis. There is no requirement to retrospectively apply a harmonised standard as there is no requirement to actually use harmonised standards; it just leads to presumed conformity.

I think it is entirely reasonable to carry out a gap analysis between the old and new standard (or the method previously used and the brand-new standard). The differences could be risk assessed and then this used as a justification for retrospectively applying particular clauses.

I think a reasonable NB would accept this approach
 

Peter Selvey

Staff member
Super Moderator
#7
For MIREGMGR: the FDA has already made clear they do NOT require retrospective application. Canada also does not require it. So at this stage, only Europe is driving retrospective application, at least according to NBs.

For pkhost: absolute right, a gap analysis and risk based decision to apply retrospectively is reasonable. But there is a draft NB-MED in preparation that indicates that retrospective application means a full test report of ~150 pages showing a verdict for all ~1,400 requirements, for each individual medical device. The verdicts don't need to be "Pass", because the standard is voluntary. But they say you still need the 150 page report. And if any individual verdict does not comply, then you need to write your alternate solution, which will be closely checked by the NB for plausibility. That's a huge amount of work, so this is not a trivial interpretation.
 
M

MIREGMGR

#8
For MIREGMGR: the FDA has already made clear they do NOT require retrospective application. Canada also does not require it. So at this stage, only Europe is driving retrospective application, at least according to NBs.
I expect FDA to set aside their past informal action in this area and formally re-address it after June 2012. They have little political choice, because they'd be exposed to Congressional ire if they allowed devices to stay on the market with less-than-current-defintion-of-"safety" characteristics and newsworthy harm was attributed to such a device. When that reconsideration occurs, the presented case in my view could justify a continuation of the time-of-design stance if it successfully argued that cost-of-care is societally important enough to justify greater individual risk.

Aside from the above, there are a few folks within FDA who continue to think that harmonization is a good idea. This is one of those points on which harmonization has a very specific effect.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
I expect FDA to set aside their past informal action in this area and formally re-address it after June 2012. They have little political choice, because they'd be exposed to Congressional ire if they allowed devices to stay on the market with less-than-current-defintion-of-"safety" characteristics and newsworthy harm was attributed to such a device. When that reconsideration occurs, the presented case in my view could justify a continuation of the time-of-design stance if it successfully argued that cost-of-care is societally important enough to justify greater individual risk.

Aside from the above, there are a few folks within FDA who continue to think that harmonization is a good idea. This is one of those points on which harmonization has a very specific effect.
Isn't the whole principle of weighing risk against benefit (in this case - affordability) intended to be applied on an individual device basis? I'd think the variation of electrical devices and their individual circumstances is too wide to make a generic call.
 
R

rsavoie

#10
Hi Peter,
I would be keen to read the article you posted, but the link doesn't work anymore. Can I find it somewhere else or perhaps would you mind emailing it to me?

What we lack in resources for taking on the EU courts, we probably make up for in motivation and enthusiasm. Implementation of this standard is a nightmare!
 
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