I’m A UK Manufacturer, Do I Need To Hold The File In The EU?
If you’re supplying machinery or other products into the EEA, you need an EEA based organisation to act as the representative compiling the Technical File. They will make the file available to any Authorities that request it. The name and address need to be provided on the Declaration. Following Brexit, the UK is not part of the EU. Therefore, UK Manufacturers will require to have the files available in the EU.
Regulation EU 2019/1020 in July 2021 will require an importer, fulfilment centre or Authorised Representative.
Why Do I Need This Service
Manufacturers of machinery are required to identify on their Declarations of Conformity or Incorporation the person who will act on their behalf. The manufacturer needs to supply the name and address of said person. This representative within Europe acts on their behalf to ‘compile’ the Technical File for their machine. As well as, provide the Technical File, on official request from a European enforcement agency.
If a manufacturer already has an Authorised Representative or office based in the EU, they will be able to fulfil this requirement. However, some manufacturers do not have a relationship with a company based in one of the twenty-seven EU countries. In this case, they can store their Technical Documentation with Hold Tech Files Ltd.
If a manufacturer does have an authorised representative in the EU, the manufacturer does not have to use them as a means of providing the Technical File to the European enforcement agencies. On occasion, Authorised Representatives represent more than one company or organisation, and may provide similar equipment. So, the manufacturer may not be comfortable in their Authorised Representative having access to the Technical File.
Using An Importer
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 certified marking is correct.
Industrial Washing Machines Ltd & Our EEA Representative
Hold Tech is our official EU technical file agency. They act as our Authorised Representative as a we are a non-EU manufacturer. In addition, they house the documentation on behalf of IWM in order to work with any Authorities that may request it.
Furthermore, Hold Tech Files Ltd. will securely hold a copy of the Technical Documentation and make it available to authorities. They review the technical documentation and ensure it is compliant for purpose.