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

Peter Selvey

Staff member
Super Moderator
#11
Unfortunately I attempted an upgrade of the software hosting the website, and the whole lot was lost. I'm slowly uploading material using a back up. I just added this page now, although I can see the formating needs a little tweaking ...
 
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R

rsavoie

#12
Thanks!
Sorry to hear about your CMS crash...maybe time to switch to Joomla? haha.
Good thing you had a backup.

I'll take a read of the article and post back. Again, thanks for reposting.
 

michael Cejnar

Involved In Discussions
#13
Peter Selvey,
I read your article and it the first comment I saw that makes any sense to me. I agree that the pre-amble clearly suggests conformity at the time of design. This should be widely circulated and the industry associations certainly should pursue this in he courts - where are they?


If retro-testing of designs is required, this whole issue seems surrealistic.

The situation as I see (happy to be corrected):

1. By July 2012, the probable tens of thousands of medical devices on the market in EU need to be retro-tested to Ed3 to be sold.

2. I am told by two trusted sources in Australia that there are no Ed3 accredited test laboratories in Australia and probably not in South East Asia (happy to be corrected on this).

3. From the uncertainty in threads and from a UL presentation just this week in Sydney, it is hard to find anyone who has actually competed an Ed3 Report - tester or manufacturer, so I doubt many EU devices are already tested.

4. Someone mentioned that Ed3 testing is currently taking 6 months to complete - and I can believe this.

5. What about devices that have to be modified to comply to Ed3 - how much longer will that take?

I just don't understand how this is going to be accomplished. Anyone want to wager that come July 2012, lack of 'presumption of conformity" will be deferred ?

I think I like best the option of assuming non-retro-testing and performing risk analysis on new Ed3 requirements and addressing and testing only those significantly improving safety, or perhaps even just those, where new requirements have exposed an unacceptable risk. Of course this may not get much sympathy, in my experience, the NB rarely argues the law - they simply say these are the terms of our commercial contract (e.g. retro-testing) if you want our CE mark.

PS: One more thought, if devices need modification to design to pass Ed3 regardless if it improves safety for that device, (which with the 2200 or 2400 items seems probable), patients by definition will receive no benefit and only the risk of introducing errors or hazards by changing software / hardware designs. How can this be justified? Conservatives say "Things that do not need fixing, need to not be fixed."
 

Peter Selvey

Staff member
Super Moderator
#14
I'm suspecting that it would be a brave NB that would go so far as to cancel a certificate; rather they would just raise audit non-conformities and accept a plan of action.

Unfortunately this flexible approach allows the issue to stay unaddressed. If the NBs were strict in their interpretation (not only for EN 60601-1 but for all harmonized standards), the issue would quickly get raised to EU commission level and they would surely come back with a "time of design" ruling, as it's the only one that can work broadly.
 
C

celeo

#15
Thanks for raising this issue Peter. It has resulted in my asking a series of questions directly to the NB and specifically their person who sits on the IEC committee that created/published the 3ED.
In the interim I would suggest that a manufacturer would be wise to at least do a gap analysis ('delta' report) between the 2ED and 3ED on MDD class IIa and higher risk devices.
There are very limited global test house resources with 3rd party accreditation to produce 3ED test reports / certification. Thus a log jam of manufacturers wanting product tested is bound to occur prior to June 2012.
Therefore a delta review as soon as possible for any existing device would be a recommendation to determine if testing of the differences is necessary.
For new designs it is obvious - get the product to an accredited test house ASAP. Self testing is NOT an option.
 
P

PaulGr

#16
Hi Peter,

Very nice article! :agree1: I think, in practice, not so many manufacturers will start this 'theoretical fight' with their NB, especially since they want them to be a little flexible with the June 1st date...

In my opinion, no manufacturers will loose their CE certificate on June 1st 2012 as a result of 3th edition non compliance. But I expect within a year notified bodies will put a lot of pressure on those manufacturers not yet ready. Those without any action plans or no testing started will definitely get in trouble.

I've been involved in discussions with a notified body about this 'Whereas' section of the MDD. In the end, they insisted on using the more recent standards. Basically, they regarded new standards as 'state of the art' and we would then need to substantiate why the old standards would also still classify as 'state of the art'.

And some remarks on the post of Michael:

1. By July 2012, the probable tens of thousands of medical devices on the market in EU need to be retro-tested to Ed3 to be sold.
When particular 60601-2-xx standards apply for your product, the transition period of the particular applies. Many are later than July2012 so this will spread the peak.

3. From the uncertainty in threads and from a UL presentation just this week in Sydney, it is hard to find anyone who has actually competed an Ed3 Report - tester or manufacturer, so I doubt many EU devices are already tested.
I have recently seen many devices from European manufacturers tested and compliant with 3th edition... Some manufacturers are still on schedule to be ready before June.

4. Someone mentioned that Ed3 testing is currently taking 6 months to complete - and I can believe this.
If your risk management file is incomplete and some redesign is needed to comply, I can imagine it will take more than 6 months. On the other hand, I've seen actual testing finished within weeks.
 

michael Cejnar

Involved In Discussions
#17
Thanks PaulGR for some answers.

May be I am being Don Quichotte, but I am not convinced this "at the time of the design" is a theoretical fight, it is a question of law at the core of the MDD, and should not be conflated with NB's arbitrary contractual conditions, of which retrospective retesting seems to be one.

Regarding flexibility, attached Draft NB-MED leaves no doubt about retesting deadline being June 2012, and TUV SUD's Webinar on 13th July 2011 had a diagram and text clearly stating that absence of Ed3 or clause by clause evidence on June 2012 means "MEE Illegal to put on market" and "Stop Production". So yes, I too will be hoping for my NB to be in a good mood and break EU Law for me by allowing me to keep supplying EU. (same principle for EU's PIGS budget deficits is working out well....)

In a rare moment of candor the above TUV webinar also admits that there are so many problems with Ed3 because it was not validated (by testing a few MEE) before being published. ...Not confidence inspiring for our business.

Lastly, what about 3rd party medical components and accessories - Globtek does not have our medical power supply Ed3 retested - so how could we have tested our system in the 'transition period' or even how do we test now?


I believe the Medical Industry should argue for:

1. Defer Transition period for Ed3 until at least Amd1 to fix known errors

2. Give proper 2 year transition from Amd1 (5 years with a crazy standard and no test labs in which to test was not a real transition).

3. Cut out retrospectivity on existing designs unless risk-based and retest on next major design change. If as they argue that we make a hundred design changes every year, so we might as well retest by June 2012, then the opposite argument holds - the NB can easily get us at the next significant design change over the next 12 months - when we will be at least partly re-verifying to the new standard anyway.

4. Make Amd1a, cutting out all the "evaluate product's risk stuff" - and relying on 14971 - after all they rely on 13485 for manufacturing quality without measuring our soldering iron temperatures.

5. Ideally cutting out 1/3 of the least important requirements, or break up into two standards (e.g. one for battery / SELV operated - which should cut out all mains-related issues) (OK, this may be wishful)


Any big players out there?
 

Attachments

Peter Selvey

Staff member
Super Moderator
#18
I agree this needs to clarified legally not only for EN 60601-1 but also for the many other harmonized standards manufacturers have to deal with.

In defence of German Notified Bodies, there is 2004 document ZLG 3.5 A1, (in German) issued by the their competent authority which instructs them to issue non-conformities and withdraw certificates if technical documents are not updated to current harmonized standards prior to the date of withdrawal. So this may be coming from a higher level.

The main point that I am making is that retrospective application is impossible, if applied broadly.

A classic example: in 2001 a brand new standard appeared (IEC 60601-2-37:2001) which had major new tests for acoustic output and transducer temperature for diagnostic ultrasounds. At that time, few manufacturers had the equipment to test, even the larger companies had older sets up based on FDA requirements, which are different to IEC tests. Establishing a test set up takes around US$100,000 and 3-4 months. It takes around 1 weeks to test a single transducer; many manufacturer have 100's of transducers. Taking into account testing, (re)design time, transfer to production and the supply chain, a reasonable transition period for such a major standard would be at least 3 years, if not 5 years.

The actual time line for this standard was:

2001, July: First published as IEC
2002, June: First published as EN (by BSI)
2002, Dec: Harmonized without any transition period

In other words, just 17 months from IEC to harmonization, and 6 months from EN to harmonization.

It is almost for sure that zero (0) manufacturers complied with EN 60601-2-37:2002 on 13 of December, 2002, and it is also likely that zero (0) notified bodies were checking to make sure implementation was in place before the deadline.

A strict interpretation would require all diagnostic ultrasounds to be withdrawn from the market on 13 December 2002, placing the European public at serious risk, as well as failing to comply with the top level EU treaty on laws.

This is not an isolated case, there are many like this, including recent examples.

Thus, we are left with two possibilities:
1) the NB interpretation is wrong, or
2) the law is impossible to comply with, potentially dangerous and illegal

Out of these two choices, the first seems to be most likely.
 

Ronen E

Problem Solver
Staff member
Moderator
#19
I agree this needs to clarified legally not only for EN 60601-1 but also for the many other harmonized standards manufacturers have to deal with.

In defence of German Notified Bodies, there is 2004 document ZLG 3.5 A1, (in German) issued by the their competent authority which instructs them to issue non-conformities and withdraw certificates if technical documents are not updated to current harmonized standards prior to the date of withdrawal. So this may be coming from a higher level.

The main point that I am making is that retrospective application is impossible, if applied broadly.

A classic example: in 2001 a brand new standard appeared (IEC 60601-2-37:2001) which had major new tests for acoustic output and transducer temperature for diagnostic ultrasounds. At that time, few manufacturers had the equipment to test, even the larger companies had older sets up based on FDA requirements, which are different to IEC tests. Establishing a test set up takes around US$100,000 and 3-4 months. It takes around 1 weeks to test a single transducer; many manufacturer have 100's of transducers. Taking into account testing, (re)design time, transfer to production and the supply chain, a reasonable transition period for such a major standard would be at least 3 years, if not 5 years.

The actual time line for this standard was:

2001, July: First published as IEC
2002, June: First published as EN (by BSI)
2002, Dec: Harmonized without any transition period

In other words, just 17 months from IEC to harmonization, and 6 months from EN to harmonization.

It is almost for sure that zero (0) manufacturers complied with EN 60601-2-37:2002 on 13 of December, 2002, and it is also likely that zero (0) notified bodies were checking to make sure implementation was in place before the deadline.

A strict interpretation would require all diagnostic ultrasounds to be withdrawn from the market on 13 December 2002, placing the European public at serious risk, as well as failing to comply with the top level EU treaty on laws.

This is not an isolated case, there are many like this, including recent examples.

Thus, we are left with two possibilities:
1) the NB interpretation is wrong, or
2) the law is impossible to comply with, potentially dangerous and illegal

Out of these two choices, the first seems to be most likely.
One little reminder: Compliance with harmonized standards is not mandatory. It is compliance with the ERs which is mandatory. If you have another way to show that a device is compliant with the ERs (based on state of the art and a high level of public health and safety assurance) you should be OK.
 

pkost

Trusted Information Resource
#20
One little reminder: Compliance with harmonized standards is not mandatory. It is compliance with the ERs which is mandatory. If you have another way to show that a device is compliant with the ERs (based on state of the art and a high level of public health and safety assurance) you should be OK.
I think this is a really interesting discussion....

Although it is true that harmonised standards are not required, past experience with our NB (and I'm sure it won't just be limited to just ours) is that they are very resistant alternate approaches to demonstrating compliance if a harmonised standard exists. I would say MEDDEV's also fall under this category.

I would hope that if we pushed hard enough they would back down but to be honest the effort necessary so far has not made it worthwhile.
 
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