For those of you familiar with the CE Mark and the medical directives in the EU (e.g., Medical Device Directive, etc) you are probably cognizant that the general rule is that conformity with the harmonized standards provides a presumption of compliance with the essential requirements (Article 5.1, MDD).

I have CE Marked product for a few years now, and I recently had a device approved where the initial device design did not conform to a particular harmonized standard. I discussed the issue with the Notified Body, my argument being that the compliance with the standard is only a presumption of conformity with the essential requirements; therefore, if a manufacturer chose not to adopt a particular standard in the development, then the onus is placed on the manufacturer to substantiate direct compliance with the essential requirements through alternative objective evidence. Unfortunately, the Notified Body did not agree and indicated that the only means to substantiate compliance with the essential requirements was to comply with the harmonized standard.

I am curious to see if anyone has ever successfully challenged this paradigm. For that particular submission, I made the decision to apply the standard to the design, that was the only issue that precluded approval, and strategically it made sense since the company wanted to launch the device. Nonetheless, from a regulatory standpoint, one the main factors in obtaining CE Mark is to prove compliance with the essential requirements, not the harmonized standard.

:thanx:

For those of you familiar with the CE Mark and the medical directives in the EU (e.g., Medical Device Directive, etc) you are probably cognizant that the general rule is that conformity with the harmonized standards provides a presumption of compliance with the essential requirements (Article 5.1, MDD).

I have CE Marked product for a few years now, and I recently had a device approved where the initial device design did not conform to a particular harmonized standard. I discussed the issue with the Notified Body, my argument being that the compliance with the standard is only a presumption of conformity with the essential requirements; therefore, if a manufacturer chose not to adopt a particular standard in the development, then the onus is placed on the manufacturer to substantiate direct compliance with the essential requirements through alternative objective evidence. Unfortunately, the Notified Body did not agree and indicated that the only means to substantiate compliance with the essential requirements was to comply with the harmonized standard.

I am curious to see if anyone has ever successfully challenged this paradigm. For that particular submission, I made the decision to apply the standard to the design, that was the only issue that precluded approval, and strategically it made sense since the company wanted to launch the device. Nonetheless, from a regulatory standpoint, one the main factors in obtaining CE Mark is to prove compliance with the essential requirements, not the harmonized standard.

:thanx:
Direct your NB to this site
The New Approach to technical harmonisation and standardisation - Harmonised Standards: Introduction (http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/introduc.html)

"Compliance with harmonised standards remains voluntary, and manufacturers are free to choose any other technical solution that provides compliance with the essential requirements."

Al you are psychic! (LOL, that was a poor joke to a thread I was just reading about psychics!)

Actually, I did refer the NB to that reference. Quoted it verse and chapter, and provided hard copy and the html link to the guidance document (http://europa.eu.int/comm/enterprise/newapproach/legislation/guide/document/1999_1282_en.pdf). Unfortunately, they were pretty steadfast and still maintain that conformance to the harmonized standard is not an option.

Rather than fight the issue and cause a major delay in the product launch (and have executive management put me on their black list!) I went ahead and did the work to apply the standard. If I had additional time as part of the submission, I would have tried to fight it and pushed the NB to provide verse and chapter as to why conformance with the harmonized standards is voluntary. However, I would much rather purse such an argument if I had primary authority to substantiate the claim. Unfortunately, I know very little about international law, and I do not know if the reference I have provided is based on primary authority or if it is merely persuasive authority.

There are a loooooot of NBs and most of them have an opening mind.

I'm curious. How high up in the food chain of the NB did you go before you decided to take what seemed to you the path of least resistance?

I hope you didn't stop with just the site auditor or his immediate superior. It's often surprising how much LESS RIGID a top official is than the petty bureaucrats who do more to undermine than support the organization.

When we train our assessors to audit on behalf of the Notified Body, we do take time to explain what is meant by "harmonised". Usually - hopefully always! :) - it sinks in.

But I'll be the first to agree that it isn't necessarily the easiest concept in the world, especially for assessors from countries with a strict governmental "this-is-how-you-WILL-do-it" approach.

However whilst the strict answer to the original question is "you are never required to meet any standards in order to demonstrate conformity", the reality is not quite so clear cut. There are several harmonised standards that are so well-established, that compliance with them is essentially expected.

Now if you believe your company has a way to demonstrate compliance which avoids meeting such a standard, all well and good. But I'll be looking awfully closely to confirm that. :cool: