Article 3 of the Regulation provides definitions for these four terms.
If a manufacturer is based outside the EU, the options for an economic operator are restricted to an importer, AR or fulfilment service provider. For industrial products or those where regulatory compliance is complex, it is unlikely that an importer or fulfilment service provider will be competent or willing to take on the responsibilities of being the economic operator. Furthermore, if a manufacturer appoints an importer as the economic operator, this could entail sharing valuable intellectual property contained in technical files, which manufacturers will be reluctant to do. This leaves an AR as the only viable option.
An AR is defined in Regulation 2019 / 1020 as any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer’ s obligations under the relevant Union harmonisation legislation or under the requirements of the Regulation.
Appointing an AR may seem like a simple administrative exercise but note that the AR needs to be competent to understand the conformity documentation and ensure it is suitable for purpose, and must be capable of responding to enquiries from market surveillance authorities.
To bolster market surveillance, the EU has established a Union Product Compliance Network. This serves as a platform for structured co-ordination and cooperation between enforcement authorities of the Member States and the European Commission. In addition, it streamlines the market surveillance within the EU and makes market surveillance more effective. This Union Product Compliance Network makes it all the more important that manufacturers meet the requirements relating to economic operators. If customs checks on documentation reveal there is no economic operator established in the EU, goods can be held at customs.
For manufacturers outside the EU needing to appoint an EU AR, Hold Tech Files Ltd is based in the Republic of Ireland and is therefore established in the EU as required by Regulation 2019 / 1020. The company offers a service whereby it acts as an AR for any of the Directives listed in Annex I. This includes the Directives relating to industrial products as well as others ranging from aerosol dispensers, boilers and fertilisers, through to chemicals( REACH), cosmetics and weighing instruments.
Although the Machinery Directive 2006 / 42 / EC predates Regulation 2019 / 1020, one of the Machinery Directive essential health and safety requirements( 1.7.3) states that the machinery must be marked visibly, legibly and indelibly with the business name and full address of the manufacturer and, where applicable, his authorised representative. In effect, this means the AR’ s details must be provided on the manufacturer’ s plate on the machine.
Note that the new Machinery Regulation( EU) 2023 / 1230, which replaces the Machinery Directive in 2027, is more specific about the roles and responsibilities of ARs with regard to machinery.
For machine builders, system integrators and suppliers of safety components falling within the scope of the existing Machinery Directive, the requirement in Regulation 2019 / 1020 for an economic operator is additional. Manufacturers outside the EU must still name a person established in the EU on the Declaration of Conformity( DoC) or Declaration of Incorporation( DoI) as being authorised to compile the technical file. For clarity, it would be advisable to name the person authorised to compile the technical file separately from the AR, even though it is simplest if both are, in fact, the same person.
As well as being appointed as an AR, Hold Tech Files can also be named on the DoC or DoI as the person authorised to compile the technical file. For this second service, Hold Tech Files has created a simple web-based portal where clients can sign a mandate, pay a fee and upload the relevant file to a secure server. The client is then entitled to name Hold Tech Files on the DoC or DoI for a period of up to ten years. This period can be extended, the files modified or updated, and more products added, all via the selfservice portal.
Visit the website or send an email to find out more about appointing an Authorised Representative and naming Hold Tech Files Ltd on the DoC or DoI as being authorised to compile the technical file for machines, partly completed machines and safety components covered by the Machinery Directive. www. holdtechfiles. eu and derek @ holdtechfiles. eu
www. holdtechfiles. eu and derek @ holdtechfiles. eu