I'm a UK based manufacturer of CE Marked products/equipment. I sell my products/equipment within the EU. Do I have to submit my technical file to a European Authority?

In selling to the EU, there is no requirement, under normal circumstances, for you to send your Technical File to a European Authority unless you are requested to do so by them - and that, normally, will only take place when there are sufficient grounds for them to ask for it.

When selling to the EU, you will now need to comply with 2019/1020, the ‘MSA Regulation’. MSA stands for Market Surveillance Authorities. (In the UK, the MSA are such bodies as Trading Standards or the HSE). As there is no longer a link between the UK and the EU, any matters arising concerning product safety issues (e.g. product recalls) in the EU will be orchestrated by one of the EU MSAs; Trading standards will not become involved.

The EU MSA will seek contact with the ‘economic operator’ of the manufacturer in order to resolve any product safety issues. It is a mandatory requirement that if the manufacturer themselves are not established in the EU, then they must have a representative that is. This can be an authorised representative, who is one of four possible economic operators. Our sister company, Authorised Representative Service, provides this function if you would like more information on this subject.

Last updated: 2021-07-09 12:12

Posted 1 year agoby Ilonapie
#125

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