There is no escaping the fact that the UK’s trading relationship with the European Union will be different from 1st January 2021. UK machine builders exporting to the European Economic Area (EEA) must continue to CE mark their machines to the Machinery Directive 2006/42/EC as they do now, but there is one vital change for which they must be ready: a person established in the EEA has to be named on the Declaration of Conformity (DoC) as authorised to compile the Technical File. If the DoC still names somebody in the UK, then there is a risk that exported machines will be stopped at customs.
The same is also true for UK-based manufacturers of safety components that fall within the scope of the Machinery Directive. In addition, UK manufacturers of partly completed machinery, which have a Declaration of Incorporation (DoI) instead of a DoC, must name a person in the EEA on the DoI.
Larger companies may already have a subsidiary in the EU, in which case they can simply amend the DoC or DoI to show the name and address of a person in the EEA, rather than someone in the UK. However, smaller companies without an EEA subsidiary will probably not want to set one up in the final days before the transition period ends on 31st December.
Fortunately, there is a simple, expedient and cost-effective way to comply with the requirement to name a person in the EEA on the DoC or DoI. Hold Tech Files Ltd is established in Eire and can be named on a DoC or DoI as the person authorised to compile the Technical File. Note that 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.
If required, machinery safety specialists at Hold Tech Files can review the technical documentation and verify it contains sufficient information. If any shortcomings are identified, a report is prepared explaining what further information may be required.
Hold Tech Files Ltd has created a web-based service for manufacturers of machines, partly completed machines and safety components covered by the Machinery Directive. After signing a mandate and paying a fee (all fees are published on the website and there are no ‘hidden extras’), the relevant file can be uploaded and it is then backed up onto a separate server. Payment of a one-off fee entitles the manufacturer to name Hold Tech Files on the DoC or DoI for a period of ten years.
The need to have someone in the EEA named on the DoC or DoI is urgent but there is another requirement that will need to be met from July 16th 2021. To comply with EU Regulation 2019/1020 on market surveillance, UK-based manufacturers may need to appoint an Authorised Representative. The Authorised Representative not only needs a copy of the Technical File but must also ensure it is suitable for purpose. Authorised Representatives have a legal duty to provide the Technical File on request and work with the relevant authorities to ensure the product is compliant and safe for use within the EU. Hold Tech Files can act as Authorised Representative for non-EU companies supplying products into the EU.