Technical Documentation Review: Responding to a Nonconformity

[Jeffers]

Hello Elsmar,
I hope I am placing this in the correct location. This is a very rookie question, but I am having difficulty connecting certain dots regarding our Technical Documentation Submission. I submitted out technical documentation to my NB for review. Among other comments, I received the following non-conformity:

"Harmonized standard such as ISO 14971, ISO 10993, EN 980, BS EN 1041, BS EN 1641, ISO 7405 and those related to packaging test was not considered and there is no evidence that the requirements are met."

Our quality management system has been assesses and registered to ISO 13485:2003, and claims compliance with MDD. I never claimed compliance to the other standards, is this an acceptable answer/defense? I understand that ISO 14971 is referenced in 13485, but I did not see any references to the other standards in MDD or ISO 13485. How does one justify that they are not applicable?

Thank you in advance for any assistance anyone is able to provide, I would be happy to answer any additional questions if it will be helpful.

 

[shimonv]

Hello Jeffers,
There is so much to be said but let me get down to a fundamental fact:

ISO 13485 is the basic, and most commonly followed standard out there, BUT compliance to ISO 13485 does no mean compliance to MDD.
This is a very important thing to understand.

Have a look at the following link. It shows the list of European harmonized standards.

https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

Compliance with the MDD equals compliance with all the relevant standards to your organization.

I'll give you some time to digest..


-Shimon

 

[Mark Meer]

Compliance with the MDD equals compliance with all the relevant standards to your organization.

This is incorrect.

Compliance to standards is voluntary. Demonstrating compliance to harmonized standards simply bears a presumption of conformity to associated Directive requirements.

Typically (always?), harmonized standards will contain an Annex that lists the Directive requirements to which compliance to the standard equates to a presumption of conformity.

----
Jeffers,
The bottom-line is that you need to demonstrate that you meet the requirements of whatever Directive is applicable. The NB is wrong to insist that you show compliance to specific harmonized standards, specifically if you can demonstrate that you meet Directive requirements in some other way.

I suggest reading through the applicable Directive(s) for your product and developing a checklist in which you explain the evidence you have to demonstrate compliance to each Directive requirement.

For each Directive requirement, if you can cite compliance to an applicable harmonized standard, then great! Easy.
...but for other requirements, you'll have to make your own case...

MM

 

[Ronen E]

The NB is wrong to insist that you show compliance to specific harmonized standards, specifically if you can demonstrate that you meet Directive requirements in some other way.

I read the NC (as quoted) a bit differently. The NC is not necessarily about non-compliance with the harmonized standards, but about not presenting evidence that those harmonized standards were considered for application in an orderly fashion, and then rejected (for whatever documented reason).

I think that even under my interpretation the NB's statement is a little too far-reaching, because there's no requirement in the MDD to document such a thought-process. There's not even a requirement to go through such a process. However... I think this is one of those cases where it's easier to follow through than to argue. In the current situation NB expectation is almost de-facto regulation.

The gist of using harmonized standards (for MDD comliance) is accessing the highway to ERs conformity. Either way, the manufacturer will have to demonstrate conformity - through harmonized standards or otherwise; so I take it that where harmonized standards were not applied some other compelling conformity evidence exists. If that is the case, it should be easy to document an argument stating that standard X has been considered and ruled out because another solution already exists and the org prefers to preserve its resources, and so on.

 

[Marcelo]

If you change the statement to

""Harmonized standard such as ISO 14971, ISO 10993, EN 980, BS EN 1041, BS EN 1641, ISO 7405 and those related to packaging test was not considered and there is no evidence that the essential requirements are met."

it makes more sense.

Maybe that's what they wanted to say.

 

[Marcelo]

Harmonized standards are also considered the "gold" standard regarded the specific ER it covers, so if there's a related harmonized standard and you choose not to use it, it's expected that a justification (based on risk management) is provided that the level of safety is the same as if using the harmonized standard.

 

[Ronen E]

it's expected that a justification (based on risk management) is provided that the level of safety is the same as if using the harmonized standard.

(I added the emphasis)

That's exactly the problem. NBs are developing expectations that aren't necessarily in the MDD (or its preamble) and applying them as if they were regulations. What's worse, some are using the proposed new MDR as de-facto guidance to what the MDD should mean, while it's not even in effect yet, and there's a 3 year transition period ahead, after it is.

The MDD requires manufacturers (implicitly, especially those who don't apply harmonized standards) to justify how their solutions meet the essential requirements; not how they measure up with harmonized standards. This is interpretation. While that interpretation makes some logical sense, and I would support using it as a guideline or as a pointer towards improvement, everyone should remember that it's interpretation and not regulation. I wish all NBs did.

The problem might be shortcoming of expertise. With dwindling NB resources and ever expanding technology, NBs just don't have enough expertise to properly evaluate non-standard solutions (or non-harmonized, for that matter). So they fall back to the easiest route - either show you comply with a harmonized standard (not much intellectual challenge in evaluating compliance there), or show equivalence with the harmonized standard. Otherwise you're out.

 

[shimonv]

I agree with Ronen.

Mark, my statement that "Compliance with the MDD equals compliance with all the relevant harmonized standards to your organization" is not incorrect.
It's NB gospel truth

Ive' worked closely with a half dozen NB's and I have yet to see an essential requirement checklist that gets by with referencing ISO 13485 only.

I know that standards are voluntary, and you could make an argument for non-standard solution, but as they say on the Israeli roads - "Don't be righteuos, be smart".

Practically speaking, Jeffers will do well to update his list of applicable standards and the essential requirements checklist and whatever else necessary.


Cheers,
Shimon

P.S. It is unfortunate that dealings with NBs are becoming increasingly more and more bureaucratic in nature. That is my opinion.

 

[Jean_B]

ISO 16142-1:2016, though unharmonized, provides a general outline, approach and helpful table for showing which standards you (could) employ to maintain compliance with the MDD.

Note that the given standards are not exhaustive, and yet more may apply (or less) depending on your device's characteristics.
You're also expected to assure you have the proof for the claims of complying with standards you make. Too many times the standard is simply mentioned, but its full implementation isn't checked or maintained. This could also land you into trouble when the next review comes and they're expecting the outputs related to those standards.

Beyond the EU harmonized standards list given earlier (http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/)
you can also use (after some reading up on the how's and whats):
USA: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
Canada: http://www.hc-sc.gc.ca/dhp-mps/md-im/standards-normes/md_rec_stand_im_norm_lst-eng.php
Australia: https://www.tga.gov.au/standards-orders-and-medical-devices

The other region's don't come readily to mind (blame my English-centered thinking and reading).

 

[Marcelo]

That's exactly the problem. NBs are developing expectations that aren't necessarily in the MDD (or its preamble) and applying them as if they were regulations. What's worse, some are using the proposed new MDR as de-facto guidance to what the MDD should mean, while it's not even in effect yet, and there's a 3 year transition period ahead, after it is.

The MDD requires manufacturers (implicitly, especially those who don't apply harmonized standards) to justify how their solutions meet the essential requirements; not how they measure up with harmonized standards. This is interpretation. While that interpretation makes some logical sense, and I would support using it as a guideline or as a pointer towards improvement, everyone should remember that it's interpretation and not regulation. I wish all NBs did.

I do agree, however, the requirement is not that manufacturers only show compliance with essential requirements, as, related to the standards, there's this requirement:

the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full

It only requires a description, not a justification, so it's still not a requirement as I mentioned anyway.