Keeping up with "State-of-the-Art" & updated Standards

Mark Meer

Trusted Information Resource
I'm presently challenged by a legacy product that was commercialized years ago, and the design (and design docs, DHF) have not changed since. But since the time of development, several standards have been updated (e.g. 60601-1, -1-2), and there have also been other harmonized standards added to the list.

My question is: in order to demonstrate "state-of-the-art", must we continually test to new standards?
I realise the standards are (in theory) voluntary, and perhaps justification can be made to not re-test to the latest standards (as well as any new harmonized standards)...but has anyone actually done this with NB approval? If so, what approach did you use to justify not complying with newest standards, and still be able to claim state-of-the-art?

If the general approach adopted by most manufacturers is to simply ensure that products are always tested to modern standards, I'm baulking at the potential logistics here. Suppose you have 20 products. When a major revision to a standard (e.g. 60601-1 2nd to 3rd edition), is the expectation that all products be retested? The cost would be incredible!

Anyway, just curious what approaches other have with respect to continually updated standards..
Any input much appreciated!
MM
 

Remus

Involved In Discussions
You can compare old and new standard, and only perform missing tests. But you have to perfrom new standard tests. Sadly, CE marking is very expensive these days.
 

Mark Meer

Trusted Information Resource
Sadly, CE marking is very expensive these days.

Sigh. I thought as much... :(

It may also be the case for other design files? If, for example, EN 62366 (Usability Engineering), or EN 62366 (Software Life-Cycle Processes) gets updated, I presume previous documentation will have to be updated, along with the cascade of associated verification/validation activities, in order to meet most recent standards' requirements?

Like I say, with all the standards that change (and new ones added), the resources necessary to ensure all CE products are always updated is a resourcing nightmare!

----
Related question:
Suppose the legacy product was tested to 60601-1 2nd edition, and has been on the market for years. We now test to the most recent edition (3.1), and the product is found to not meet all the requirements of the new edition. What implication does this have for all the devices already sold? Technically, they are all now non-compliant, no?
 

Ronen E

Problem Solver
Moderator
I second Remus.

Related question:
Suppose the legacy product was tested to 60601-1 2nd edition, and has been on the market for years. We now test to the most recent edition (3.1), and the product is found to not meet all the requirements of the new edition. What implication does this have for all the devices already sold? Technically, they are all now non-compliant, no?

No. The requirement to keep up with the state of the art is applicable to placing units on the market. Once units have been put into use, you switch from "premarket" to "postmarket" set of requirements / expectations.
 

Pads38

Moderator
60601-1 Ed2 - Ed3

All the main electrical requirements are the same (leakage currents; creep and clear; earth currents). So if you have a Ed 2 tested device it is most likely to be OK for Ed 3.

-1-2 (EMC)

Up to the 2007 (Ed3) version it should be possible to do a 'delta' set of tests. ie some frequency ranges were extended and additional tests added.

But the 2015 (Ed 4) version is quite different and will probably require a complete re-test. The ESD tests are significantly more onerous and I foresee many difficulties.

62366 (Usability)
The latests version (2015) has an Annex C detailing a process to be used for 'legacy' devices. This has proved very useful - using real world post-marketing information you can create a report to satisfy these requirements easily and quickly.

62304 (Software life cycle)
Amendment 1 (2015) similarly introduced requirements for legacy devices. I have yet to use this so am not yet familiar with it.
 
J

jon.loo

I second Remus.



No. The requirement to keep up with the state of the art is applicable to placing units on the market. Once units have been put into use, you switch from "premarket" to "postmarket" set of requirements / expectations.

Are you able to share more on how the "premarket" and "postmarket" expectations differs in with regards to this? Where can I find more information regarding the difference in requirements/expectations between pre- and post- market?
 

Mark Meer

Trusted Information Resource
Are you able to share more on how the "premarket" and "postmarket" expectations differs in with regards to this?

Pre-market is essentially before devices are distributed on the market. So the process of CE marking, which is described in the regulations. This will (except in the case of Class I) involve assessment by a Notified Body, who will confirm conformance to the regulation's essential requirements, and often (voluntarily) involves demonstrating compliance to any applicable harmonized standards.

Post-market is after devices are out there on the market. This would be your surveillance and vigilance activities. For example, you need to have a system in place for handling complaints, recalls, and reporting adverse events. The MEDDEV Guidance documents provide some guidance. In particular, MEDDEV 2.12/1 rev.8, provides guidance on medical devices vigilance system.

MM.
 
J

jon.loo

But won't the requirements to meet the essential principles still be consistent from pre- to post- market? In this sense wont the need to conform to principles considered to be state of the art still be required for those in "post-market" phase?
 

Mark Meer

Trusted Information Resource
But won't the requirements to meet the essential principles still be consistent from pre- to post- market? In this sense wont the need to conform to principles considered to be state of the art still be required for those in "post-market" phase?

The regulations use the language "...shall be designed and manufactured...".
So:
  • If the device is in a design phase, state-of-the-art applies.
  • If the device is being manufactured, state-of-the-art applies.
  • If a given unit of the device is in the field (has already been distributed), state-of-the-art does not apply - the assumption being that it was state-of-the-art at the time it was designed and manufactured.
 

pkost

Trusted Information Resource
Regarding post market obligations, you should consider that the product at time of release is "safe and effective". An update to a standard does not make it less safe or effective.

If authorities expected recalls whenever a standard was updated and an existing product could no longer comply it would send costs skyrocketing and in all likelihood result in continual out of stocks for critical products.
 
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