What you need to do to comply with regulations on manufactured goods you place on the EU market.
This guidance is about placing manufactured goods on the EU market.
There’s different guidance if you’re:
- placing manufactured goods on the market in Great Britain
- placing manufactured goods on the market in Northern Ireland
If you placed goods on the market in an EU country (or in the UK) before 1 January 2021, you do not need to do anything. This guidance explains what you need to do for any goods you’re placing on the EU market after 1 January 2021.
Check which rules apply
What you will need to do depends on the type of goods you’re placing on the EU market.
Most of this page covers goods known in the EU as new approach goods, which can use the CE marking.
There are different rules for:
- goods regulated under the old approach (such as chemicals, medicines and vehicles)
- non-harmonised goods covered by national legislation
Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.
Old approach goods
You must follow special rules if you’re placing these goods on the EU market.
Check the European Commission’s website for the latest information.
You must make sure that your goods meet the requirements of the first EU or EEA country in which you are placing them on the market.
You will not usually need to do anything else if you then place your non-harmonised goods on the market in another EU or EEA country.
Check the national regulations of the relevant EU/EEA country to find out what you need to do.
Check if you need to change your conformity assessment
If you were previously exporting to the EU before 1 January 2021, you will not need to change your conformity assessment for exports to the EU if:
- you self-declare the conformity of your good against the regulations
- any mandatory third-party conformity assessment was carried out by an EU-recognised notified body (whether based in the EU or in a country with which the EU has a mutual recognition agreement)
- the certificate of conformity previously held by a UK body has been transferred to an EU-recognised notified body
- you voluntarily use a testing body (including UK bodies) to test against European or international standards
UK conformity assessment
Any mandatory conformity assessment needs to be carried out by an EU-recognised conformity assessment body. This includes both EU based bodies and bodies in countries with which the EU has concluded a mutual recognition agreement.
UK conformity assessment bodies cannot carry out mandatory conformity assessment for products being placed on the EU market.
Speak to your testing body or solicitor for advice on conformity processes.
Appoint an EU-recognised notified body
Check whether your UK notified body has arrangements in place to help you get certification for the EU market. This means you can export to the EU without needing to find a new EU notified body yourself.
If not, you need to either:
- get your products assessed by an EU notified body
- arrange for information held by your existing notified body to be transferred to an EU notified body so they can issue you a new certificate
Certificates and documentation
If you transferred an existing certificate to an EU notified body before 1 January 2021 then you need to update the 4-digit notified body number on your products. You do not need to do this for products already on the market or which were manufactured before the transfer took place.
You will eventually need separate certificates for the UK and EU. You should speak to both your existing and new body to make arrangements that mean you are covered for both markets.
If you transfer your certificate to the EU without doing this you may not be able to continue selling your goods in the UK from 1 January 2022 without having your product reassessed. This process may take a long time so you should start now.
EU and UK notified bodies are required to share information when requested by a certificate holder. This will help facilitate the issuing of new certificates of conformity where needed.
Appoint an authorised or responsible person
The EU does not recognise authorised representatives and responsible persons based in Great Britain.
If you’re required to, you need to appoint an authorised representative or responsible person based in the EU, EEA or Northern Ireland.
From 16 July 2021 you will need to appoint an authorised representative based in the EU or EEA if you sell goods without using an importer or fulfilment service provider. For example if you sell online and ship directly to the end user.
Check your legal responsibilities
You are responsible for:
- ensuring your product complies with the relevant EU rules
- drawing up documentation such as the EU declaration of conformity
You can delegate some of the duties to an authorised representative – you will need to check the specific EU regulations that apply to see what can and cannot be delegated.
If you have an EU based distributor they act as an ‘importer’ for the EU market if:
- they are the first one making your product available on the EU market
- you have not arranged for someone else to take on the responsibilities of the importer.
The importer needs to make sure:
- goods are labelled with their address and either your details or your EU, EEA or Norther Ireland-based authorised representative’s details (including your company’s name and a contact address or registered trademark)
- the correct conformity assessment procedures have been carried out and that goods have the correct conformity markings
- you, as the manufacturer, have drawn up the correct technical documentation and complied with the labelling requirements
- they maintain a copy of the declaration of conformity for a period of 10 years after the goods they import have been placed on the market
- goods conform with the relevant essential requirements
EU-based fulfilment service providers
From 16 July 2021, if you use an EU-based fulfilment service provider, they will need to request certain compliance information from you, and goods will need to be labelled with their details.
They may ask that you appoint an authorised representative who can fulfil these obligations instead.
This guidance is based on information published by the European Commission. For the latest updates on the EU’s requirements please consult the European Commission’s website.
Email firstname.lastname@example.org if you have goods regulation questions.