Hold Tech Files Ltd.

We Hold Technical Files and Technical Documentation securely in the EU relating to CE Marking for machinery and products, and homologation of vehicles. We act as Authorised Representative for CE Marking and Manufacturers Representative for vehicle homologation.

All CE Marking Directives, Regulations and Homologation Regulations require Technical Documentation or Technical Files to be made available to European Economic Area authorities on a reasoned request. Where the Technical Documentation is not held in the EU, this can sometimes cause difficulties.

Hold Tech Files Ltd. will securely hold a copy of the Technical Documentation and make it available to authorities. We can review the technical documentation and ensure it is suitable for purpose. We can provide a report identifying any shortcomings and explain what further information may be required.

For the Machinery Directive 2006/42/EC we will allow our name to be used as the person to compile Technical Files on EC Declarations of Conformity or Incorporation for the Machinery Directive 2006/42/EC, once the fee is paid and the file uploaded. This is the only Directive that requires this. This also applies to the Machinery Regulation (EU) 2023/1230 due to come into force in January 2027.

If you know what this means, and want to upload a Technical File or documentation you can start the process HERE.

You will need to sign a mandate that identifies the authorised representatives’ responsibilities and pay the relevant fee. Once this is done an invoice will be provided and a link provided to upload the documentation. The documentation should be in PDF format.

United Kingdom and Brexit

From January 1^st, 2021, any UK machinery manufacturers without an EU address needs a person in the EU that can act as the person to compile the Technical File. Larger companies that already have a subsidiary in the EU can simply change the Declaration of Conformity to show the name and address of a person in the European Economic Area (EEA) authorised to compile the Technical File, rather than someone in the UK.

The official ‘Guide to application of the Machinery Directive 2006/42/EC’ makes it clear that ‘The person authorised to compile the technical file is a natural or legal person’ – in other words, the ‘person’ named can, in fact, be a company. The company must be based in the EU. As the UK will no longer be a Member State, the address cannot be in the UK.

It is possible that Customs could prevent access to EU markets if documentation is not correct, and an EU person not identified on Declarations.

Hold Tech Files Ltd. is based in the Republic of Ireland.

Regulation 2019/1020

Strengthening the single market for goods through further enhancing efforts to keep non-compliant products from being placed on the Union market was identified as a priority in the Communication from the European Commission of 28 October 2015 entitled ‘Upgrading the Single Market: more opportunities for people and business’.

This is intended to be achieved by strengthening market surveillance, providing economic operators with clear, transparent and comprehensive rules, intensifying compliance controls and promoting closer cross-border cooperation among enforcement authorities, including through cooperation with customs authorities.

This led to the introduction of Regulation 2019/102 which came into force on July 16^th, 2021. This then lead to the requirement for non-EU manufacturers to sell through an importer, fulfilment centre or have an Authorised Representative based in the EEA.

It is intended that market surveillance authorities should have access to all necessary evidence, data and information relating to the subject matter of an investigation in order to determine whether applicable Union harmonisation legislation has been infringed, and in particular to identify the economic operator responsible, irrespective of who possesses the evidence, data or information in question and regardless of where it is located and of the format in which it is held. Market surveillance authorities should be able to request economic operators, including those in the digital value chain, to provide all the evidence, data and information necessary.

The ‘importer’ is defined as any natural or legal person established within the Union that places a device from a third country on the Union market;

The importer has legal duties to ensure the product is CE Marked correctly and has suitable supporting documentation. They must keep records of any complaints or problems, and act on them in a timely manner. The documentation must be kept for ten years from the last product sold.

A ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

An ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation;

Market surveillance authorities will have the power to recall or withdraw products from the EU Market.

Authorised Representative

We can act as Authorised Representative for non-EU manufacturers, and hold the documentation on behalf of the manufacturer, and work with any Authorities that may request it.

From July 2021, EU Regulation 2019/1020 on Market Surveillance required all product suppliers into the EU to have an importer, fulfilment provider or Authorised Representative who will be able to supply the relevant documentation to the Authorities on request.

Different Directives have slightly different requirements. In general, the Authorised Representative has a duty to ensure the documentation is adequate and suitable for purpose and provide it to any reasoned request from an authority in any EU country.

An ‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;

If you sell into the EU using an importer, the importer has the responsibility to ensure the product is CE Marked and safe. The importer needs a copy of the Technical File. If the importer represents several similar products, this can lead to conflict of interest.

If supplying via a fulfilment centre, the fulfilment centre has the responsibility to supply the Technical File to authorities on request. They should ensure the product is suitable for purpose and CE Marked correctly.

If neither of these alternatives are acceptable, and there is no EU representative, then an Authorised Representative will be required. The Authorised Representative needs a copy of the Technical File, but also needs to ensure it is suitable for purpose, as they have a legal duty to provide it on request, and work with the Authorities to ensure the product is compliant and safe for use within the EU. Hold Tech Files Ltd. can act as Authorised Representative for non-EU companies supplying products into the EU.

Manufacturer’s Representative

We can act as Manufacturers Representative for vehicle manufacturers in regard to Vehicle Homologation, see link.

The ‘manufacturer's representative’ is defined in EU Regulation 2018/858 as any natural or legal person established in the Union who is duly appointed by the manufacturer to represent the manufacturer before the approval authority or the market surveillance authority and to act on the manufacturer's behalf in matters covered by this Regulation;

For the purposes of EU type-approval of vehicles, systems, components and separate technical units, a manufacturer established outside the Union shall appoint a single representative established within the Union to represent the manufacturer before the approval authority. That manufacturer shall also appoint a single representative established within the Union for the purposes of market surveillance, who may be the same as the representative appointed for the purposes of EU type-approval.

The manufacturer's representative shall perform the tasks specified in the mandate received from the manufacturer. That mandate shall at least, provide for the representative to:

have access to the EU type-approval certificate and its attachments referred to in Article 28(1), and to the certificate of conformity in one of the official Union languages; such documentation shall be made available to the approval authorities and to the market surveillance authorities for a period of 10 years after the end of the validity of the EU type-approval of a vehicle and for a period of five years after the end of validity of the EU type-approval of a system, component or separate technical unit;
provide an approval authority, following a reasoned request from that authority, with all information, documentation and any other technical specifications, including access to software and algorithms, that are necessary to demonstrate the conformity of production of a vehicle, system, component or separate technical unit.
cooperate with the approval authorities or the market surveillance authorities, at their request, on any action taken to eliminate the serious risk posed by vehicles, systems, components, separate technical units, parts or equipment covered by that mandate;
immediately inform the manufacturer about complaints and reports relating to risks, suspected incidents or non-compliance issues that relate to vehicles, systems, components, separate technical units, parts or equipment covered by that mandate;

Legislation

Please go to the Directive page that applies. If your product is affected by any of this legislation, you need an importer, fulfilment centre or Authorised Representative to hold technical documentation within the EU.

Medical Devices

We do not act as Authorised Representative for Medical Devices.

The situation for medical devices is slightly different in the fact that the Representative is legally liable for defective devices if a manufacturer established outside the Union has not complied with its general obligations. The authorised representative is jointly and severally liable with the importer and the manufacturer. There are specialist companies that carry out this function.

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