Stress free guide to product compliance

2021-02-19
ProductIP
Beginner

Product Identity

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

What is the trace from your article number to your compliance evidence?

Obligations

Companies that place products on the EU market always have to fulfil at least the following two obligations:

  • Place only compliant products on the market and carry out a conformity assessment.
  • Keep the technical file with conformity assessment information available for at least ten years

Technical file

The technical file shall cover the relevant information about the assessment and the description of the product itself.

In practice a technical file contains at least the following elements:

  • Identification: the model number, type number, batch number, serial number or other similar references to identify the products.
  • Description: pictures of the product, artwork of packaging, design artwork, mechanical or electrical drawings, a list of materials and components.
  • Results: Evidence related to the conformity assessment such as test reports, certificates, attestations and declarations.

 Market surveillance

Whenever asked by a national authority the relevant parts of the technical file must be provided to that authority by the company that places the product on the market.

Consistency

In many cases the compliance evidence such as test reports is provided by the supplier. The tests have been performed on his behalf. The test reports will refer to his company and to the product reference of the supplier.

This product reference in the test reports may deviate from the product identification and description that is used by the buying company that markets the product under his own model or type reference.

It is important to realise a link, or a trace, between both references: from the suppliers’ to the buyers’ identification.

So, it must be clear that the evidence in the file is about the product that is in the file.
Photographs can be helpful, but it is common to ask the supplier for a ‘Declaration of Product Identity’.

The declaration simply states that the product with the suppliers’ reference in the conformity documentation is identical to the product with the purchasers’ reference.

DoPI

The Declaration of Product Identity (DoPI) can be a very brief statement about the link between both product reference (see example).
The document is signed by the supplier (because he “owns” the evidence) and added to the technical file.

Series of products

The product identity declaration can also be used to declare that a series of products are identical and only deviate in aspects that are not relevant for the conformity of these products.

Example

[supplier heading]

Declaration of Product Identity

[supplier name and address]

We, [supplier company name] declare that our product(s) with our identification
[Product ID reference of supplier] and as supplied to
[buyer company name]
are identical to the product(s) with identification
[Product ID reference of buyer].

[Representative person supplier] [Job title]
[Place and date]

[Signature] [Company stamp]

 

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