Traceability Requirements

Traceability is the ability to verify the history, location, or application of an item by means of documented recorded identification. – Wikipedia

Traceability requirements are essential in CE marking, as they support the market surveillance. They are designed to trace the history of the product and include procedures such as labelling the product and identifying the economic operators in the supply chain (manufacturer, importer, distributor, retailer).

The traceability of the product’s history is important because it makes the enforcement of corrective measures, like withdrawals and recalls, possible. This is achieved by looking at the roles of the economic operator along the supply chain, which leads to the determination of non-compliant products. In other words, this enables market surveillance authorities to trace the products from the factory gate to the consumer. Traceability requirements also help the manufacturer maintain effective control of the production phase and the suppliers, as well as reduce the impact of corrective measures, depending on the traceability system used.


Traceability provisions

EU legislation is prescriptive only in terms of requirements, without imposing the means to meet the provisions. It also does not foresee any specific type of technology to be used, such as printing or moulding, leaving the choice of the traceability system to the manufacturer, depending on what is most appropriate for the product and the distribution system.

A key traceability requirement is the indication of the manufacturer’s name and address on the product, as well as the importer’s if it is the case. This allows the market surveillance authorities to contact the economic operator responsible for placing the unsafe products on the market. There is no explicit obligation to precede the address/addresses by the works ‘Manufactured by’, ‘Imported by’ or ‘Represented by’, but there is an implicit one, in order for the Legislator to identify the role of each economic operator on the chain. However, it is not required to translate this information in all necessary languages.

The legal provisions establishing the practices regarding traceability can be found in Regulation (EC) 765/2008 and Decision 768/2008/EC. More specifically, the following is required from the economic operator:

1. Indication of name and address of manufacturer:

Manufacturers must “indicate their name, registered trade name or registered trade mark and the address at which they can be contacted, on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted.” (European Commission, 2013) This is an obligation regardless of whether the manufacturer is located in the EU or not. Cases where affixing the name and address on the product is not compulsory are the ones where the technical or economic conditions make it unreasonable. For example, products such as hearing aids are too small to carry this information. The assessment of these conditions is to be made by the manufacturer. Only one single contact point in the EU is allowed, which does not have to be the location where the manufacturer is established; it can also be the address of an Authorized Representative.

2. Indication of name and address of importer:

For importers, the same rules apply as for manufacturers. However, the importer must not place the name and address in such a way that it covers the information provided by the manufacturer. Also, if placing the name and address on the product implies opening the package the importer shall provide this information on the package.

3. Identification element:

Manufacturers also have “to ensure that their products bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.” (European Commission, 2013) They can opt for the preferred identification element, as long as it makes traceability possible. If it is the case, the identification element is the same as the one used in the EU Declaration of Conformity. If the product is composed of several parts, the manufacturer may choose between placing the identification number on the package/accompanying document, using additional markings for the individual components or giving an item number (the ‘SKU’ – stock keeping unit) to the whole product, which would also be the one enclosed within the EU Declaration of Conformity.

4. Identification of economic operators:

Economic operators have to “identify any economic operator who has supplied them with a product and any economic operator to whom they have supplied a product,” (European Commission, 2013), excluding the end consumer, who for the purposes of the relevant legislation is not considered an economic operator. This applies for a period of minimum 10 years. The compliance procedure with this requirement is not explicitly described; however, it is recommended that economic operators keep the documents which enable traceability (e.g. invoices) for a longer period of time in case they have to be presented to the market surveillance authorities.

European Commission. (2013). The ‘Blue Guide’ on the implementation of EU product rules.

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9 thoughts on “Traceability Requirements”

  1. Diana, great explanation of the requirements for economic operators to identify themselves. People often mistakenly believe that traceability requirements only apply to medical devices, but this is not true as you have explained. Thanks for the great overview!

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