Referencing Harmonised Standards in Declarations of Conformity

[Mark Meer]

Question:
When referencing harmonised standards on a declaration of conformity (DoC), what is done when a standard is only partially applied? Are you expected to:

• spell out each individual clause of the standard that was applied?
• reference the standard, but maintain internal documentation supporting the clauses applied, and rationale for exclusions?
• not reference partially-applied standards on DoC?
• (anything else?)

NOTE: I realise that referencing harmonised standards in a DoC is not a requirement of the MDR (only references to CS are required by Annex IV), but in our case our medical device has a radio, so Directive 2014/53/EU (RED) applies, which does explicitly require harmonised standards to be on the DoC (as per Annex VI).

 

[shimonv]

How about maintaining two DoCs: One for MDR without harmonised standards (keep it simple), and one for RED with a list of harmonised standards. The letter will be offered to whoever asks for it. Also, if the standard in question is not a pivotal standard perhaps the best approach is not to include it.

Shimon

 

[CharlieUK]

The RED requirements apply only to the RED
A manufacturer should issue a "single" DoC covering all applicable Directives - however a "single" DoC can be be more than one page - so you could have MDR on page 1 of you PDF and RED and RoHS on page 2

 

[Mark Meer]

Thanks for the replies, but irrespective of whether different Directives' conformities are declared independently, my main inquiry is regarding how to deal with partially-applied harmonised standards.

...if the standard in question is not a pivotal standard perhaps the best approach is not to include it.

But what if, for argument's sake, it is a pivotal standard? At the end of the day, use of harmonised standards is just a tool by which one can demonstrate compliance to general safety and performance requirements. As such, it's certainly foreseeable that a manufacturer might not choose to apply any harmonised standard in full, opting instead to selectively apply clauses where most effective, and uses other methods where deemed more appropriate.

In such cases, would such a manufacturer simply not cite any standards on their declaration, even though standard were employed, albeit partially?

 

[CharlieUK]

The wording in various directives is something like:

Presumption of conformity of equipment
Equipment which is in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements set out in Annex I covered by those standards or parts thereof.

And the DoC should contain "References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared....."

The DoC is often the 1st thing that market enforcement would look at - so make sure you at least list the standards that you think they would expect to see, so as to minimise chance for further questions