Harmonised Standards on DoC (Declaration of Conformity)

[rob73]

Hi All
Is it still valid to list standards on the declaration of conformity which are no longer harmonised? Obviously presumption of conformity based on the standard alone would be invalid (as they are no longer harmonised), but can they still be listed?

Cheers
Rob

[J0anne]

In Reply to Parent Post by rob73

Hi All
Is it still valid to list standards on the declaration of conformity which are no longer harmonised? Obviously presumption of conformity based on the standard alone would be invalid (as they are no longer harmonised), but can they still be listed?

Cheers
Rob

You may list harmonised standards or any other normative documents such as national technical standards and specifications

[Chrisx]

Yes, but why would you want to list the standards on the DOC? The standards should already be referenced on the Essential Requirements checklist. Having them cited in two documents only increases the chance for a discrepancy. It also doubles the number of documents that have to be updated when a standard is revised.

[Marcelo Antunes]

Yes, but why would you want to list the standards on the DOC? The standards should already be referenced on the Essential Requirements checklist. Having them cited in two documents only increases the chance for a discrepancy. It also doubles the number of documents that have to be updated when a standard is revised.

There's a decision from the EC regarding the contents of the declaration of conformity of directives - see http://elsmar.com/Forums/showpost.ph...9&postcount=15

[J0anne]

In Reply to Parent Post by Chrisx

Yes, but why would you want to list the standards on the DOC? The standards should already be referenced on the Essential Requirements checklist. Having them cited in two documents only increases the chance for a discrepancy. It also doubles the number of documents that have to be updated when a standard is revised.

From a Regulatory and marketing viewpoint, it can be beneficial to list standards in a DOC.

I am not sure why it would introduce any chance of discrepancy.
If your documentation is maintained correctly, there will be no discrepancies.

[Pads38]

Another "you learn something every day.."

I was going to state that none of our DoCs have any reference to standards, harmonised or other. But following Marcello's link to the EC decision 768/2008 (so it's official!) and the Annex 3 of that document -

ANNEX III
EC DECLARATION OF CONFORMITY
1. No … (unique identification of the product):

2. Name and address of the manufacturer or his authorised representative:

3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):

4. Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):

5. The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: . . . . . . . . . . . . . . . . . . . . . .. . . .

6. References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:

7. Where applicable, the notified body ... (name, number) … performed ..description of intervention) … and issued the certificate: …

8. Additional information:

Signed for and on behalf of: …………………………………
(place and date of issue):
(name, function) (signature):

[Chrisx]

I'm not sure how 768/2008/EC relates to standards listed on the DOC. Article 5 does state "all information required for the identification of Community harmonization legislation to which the declaration relates, and giving the publication references to the acts concerned". I would not think that this means standards. Standards are not legislation. Is this the reference in the legislation that we are discussing?

Annex III requires that the DOC reference the standards used for product testing. This conformity assessment route is very rarely used. If anyone is using type testing, then the standards do need to be referenced. For the other 99% of the medical devices out there, it is my opinion that standards are not necessary.

When I used to work for a notified body, I was trained to assess the DOC against the attached EK-Med guidance. The guidance states that the reference of standards is optional. No regulatory agency should make you reference a standard. Standards are not law. However, I know that they sometimes do require it.

There were endless internal decisions regarding whether we should require standards to be referenced. The final decision of the certification body was that standards were not required to be referenced. Your results may vary with your own notified body.

[Chrisx]

Ah, I see now. You meant Annex III of 2008/768/EC, not Annex III of the MDD. Sorry for my mistake. I had not seen this before. I still don't think I will revise our DOCs. I think it very unlikely that any auditor will know about this document. However, this is good information to know.

Thanks,
ChrisX