Harmonized Standard Compliance Question

[tebusse]

Greetings everyone!

I have what may seem like a not so intelligent question, but since I'm new to the regulatory and compliance world, I feel the need to inquire.

For the CE marking process in which we state that we comply with a specific standard, do we have to comply with everything within the standard? Are we able to document a specific section? For example, EN 980:2008 or BS EN ISO 15223-1:2012 - not all of the labelling or symbols will pertain to us.

Any assistance would be greatly appreciated.

Regards, Tonia

 

[isoalchemist]

You comply with the standard by using all of the symbols that pertain to your product. If at some point you need to add a symbol you use one that is provided in the standard for that description. The standard in these cases are to provide consist representations of the same information for ease of information exchange.

 

[tebusse]

Thank you, Isoalchemist. That leads me to ask another question, though. Does this concept pertain to other standards, such as ISO 14971? My company does comply with ISO 13485 and have earned our ISO Certificate.

Regards, Tonia

 

[Ronen E]

Thank you, Isoalchemist. That leads me to ask another question, though. Does this concept pertain to other standards, such as ISO 14971? My company does comply with ISO 13485 and have earned our ISO Certificate.

Regards, Tonia

Hi,

You can comply partially, as long as you're consistent in your declarations and justifications. The NB will only relate to your compliance to the extent declared and implemented.

If all parts you skip are plain "not applicable", I reckon you don't have to detail that in your declarations, but be sure to have a documented rationale for every non-applicability.

Cheers,
Ronen.

 

[tebusse]

Thank you, Ronen. This helps me tremendously!

 

[Ron Boumans]

In addition to Ronen: the CE-marking means that the product complies with the applicable directive. The manufacturer can refer to standards to prove this compliance. Not all of those standards may be applicable and sometimes the standards are not covering all of the aspects of the product. This gives room for some interpretation. Be smart if you do so.

Example: for wheelchairs there are standards with testing methods based on average users. Tests for stability are based on a limited range of patients weights and positions of the center of gravity. Manufacturers of wheelchairs for children or obese patients will not be able to test those aspects within the standard. But still their products can be compliant with the directive.