Regulatory Open Forum

Looking for confirmation regarding scope of DoC. We have submitted several Docs supporting CE Mark submissions. We are now registering in a new country that is requiring DoCs for all our products. The question came up as to whether we can list multiple product families on the same DoC to reduce costs for apostille. There is nothing in Annex II defining the  scope of the DoC content.  It is my understanding the the DoC provided for foreign registration needs to match the as submitted for the CE Mark.

Correct assumption?

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Alan Alosio
Irvine CA
United States
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I​t is acceptable for a manufacturer to include several products in the same DoC to the MDD, assuming this manufacturer manufactures all the products under the same QMS and the same Notified Body.
If you add details, like any EN standard used to cover the essential requirements of the MDD, you may have to write clearly which standard applies to which products.

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Lorenzo Muratori
Elekta
West Sussex
United Kingdom
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Original Message:
Sent: 07-Aug-2017 14:23
From: Alan Alosio
Subject: Declaration of Conformity

Looking for confirmation regarding scope of DoC. We have submitted several Docs supporting CE Mark submissions. We are now registering in a new country that is requiring DoCs for all our products. The question came up as to whether we can list multiple product families on the same DoC to reduce costs for apostille. There is nothing in Annex II defining the  scope of the DoC content.  It is my understanding the the DoC provided for foreign registration needs to match the as submitted for the CE Mark.

Correct assumption?

------------------------------
Alan Alosio
Irvine CA
United States
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Please refer to ISO 17050-1:2004 when preparing a declaration of conformity. This standard specifies requirements applicable when the organization responsible for fulfilment of specified requirements provides a declaration that a product is in conformity with those specified requirements, including other normative documents such as standards, guides, technical specifications, laws and regulations.

I hope this helps.


Original Message------

I​t is acceptable for a manufacturer to include several products in the same DoC to the MDD, assuming this manufacturer manufactures all the products under the same QMS and the same Notified Body.
If you add details, like any EN standard used to cover the essential requirements of the MDD, you may have to write clearly which standard applies to which products.

------------------------------
Lorenzo Muratori
Elekta
West Sussex
United Kingdom
------------------------------