Update CE Declaration when standards are revised?

LievenDW

Involved In Discussions
#1
Hi, I can imagine this issue has already been covered on this forum, but I can't find it.
So here's my question: when there is a new version of the harmonised standards you refer to on the Ce Declaration of Conformity, do you update all the DoC's for all your current products?
 
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Gert Sorensen

#2
When creating the DoC you use the latest revision of the relevant harmonized standard appropriate for the product. When new revisions are in place, that are relevant for the product, then a new assessment of the product should be performed, and the DoC should be updated to reflect this.

:bigwave:
 
C

CBAL08

#3
I did not know where to post this issue but was quite starnge for me to find this advertisment in some webpage... I get it for FREE:nope::nope:

MEDDEV 2.12/1 - Complete Document
Revision / Edition: 5 Chg: Date: 04/00/07
GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM

Comments:
Superseding Document:
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Peter Selvey

Staff member
Super Moderator
#4
Afterthough: the answer below is for medical devices, if your question is for non medical please ignore!
-------------------
There is a standard EN ISO/IEC 17050-1:2004 for the declaration of conformity (DoC), which requires that applied standards are shown on the DoC, but it is generic and not specific to the MDD.

It is a legal requirement in the MDD that you list the standards applied, although it does not say that you must include them in the DoC.

The MDD has a problem that there are a large number of harmonized standards that may apply to a single product (I have seen lists over a page long), so it is not practical to keep an accurate list in the DoC. As an MDD auditing over many years I never found a DoC with an accurate list of harmonised standards. Usually only a few high profile standards get a look in, and frequently the dates/amendments are wrong. Therefore, the issue of whether DoC's need to be updated & re-signed with every change of a standard is moot, while ever the standards shown are not accurate anyway.

An alternate method I have seen sometimes is to have the DoC declare compliance to the directive, and to avoid confusion, also provide a link to a separate document in the technical file which accurately lists all the standards applied including revision/amendment. I expect that as long as this list is updated, the DoC itself does not need to be re-signed with every design change, including new standards.
 
Last edited:

jkuil

Quite Involved in Discussions
#5
It is a good practice to generate for the technical file:
  • a DoC to the MDD (or other regulations for other regions), which does not include a reference to international standards, and
  • DoC to international harmonised/recognized standards referencing the version of the standard conformed to

If a standard to which conformance has been claimed is superceded, an aassessment must be made wether the process or product meets the new requirements.
For horizontal or process standards (e.g. quality system standards, risk management standards) quality system procedures must be updated to any new or revised requirement.
For vertical or product standards the following assessments must be made:
  • Do the new or revised requirements adress product safety or efficacy concerns? If not, there is no need for further investigation. Conformance to the former revision of the standard is justified. This justification must be documented.
  • Can available verification or validation data (e.g. the requirements were already adressed as user requirements in the product design) support that the product meets the new requirements?
  • Can any historic data (e.g. vigilance data) support that the product meets the new requirements?
  • If either of the above 2 questions is answered yes, then conformance to the new standard is justified. Again, this must be documented.
  • If the above 2 questions are both answered no, then the product must be verified and validated against the new requirements.

Bottom line: international standards are harmonised or recognized because governments think they adress essential requirement for safety and efficacy. Conformance to the "state of the art" standards is expected at any submission or periodic resubmission of the product file and during notified body audits of the product files (see amended MDD). I have seen more attention by NB's to the maintenance of standard conformity both by the NB and authorities. Mind you FDA assessors ofter participate in standard development, so you better adress their concerns.

BTW, it is not required to comply with the harmonised / recognized standards, the are voluntary. But you need to justify your alternative method applied to ensure your product meets the essential safety and efficacy requirements.
 
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