What is a CE mark?
The CE (Conformitè Europëenne) mark is an administrative marking placed on products that are placed in the EEA (European Economic Area) market to confirm that the product conforms with EU health and safety, as well as environmental protection requirements.
CE certification is required for any products sold in the EU, regardless of country of origin, if that is mandated by the specific EU legislation for this type of product.
Where is the CE mark recognised post Brexit?
The CE mark is recognised by all 27 member states of the EU and Northern Ireland. Products sold in any of these countries require CE markings to demonstrate compliance with the European safety standards and regulations, regardless of Brexit arrangements.
Following Brexit, the CE mark will no longer be applicable to products sold in England, Wales and Scotland. Those will require the new UKCA mark. The change comes into effect from 1 January 2021 but some products may still use the CE mark until 1 January 2022, depending on the relevant UK legislation.
What if my product was CE marked before Brexit?
It’s important to know that if you have already placed your product on the EU market before January 2021, you don’t need to do anything. However, if you would like to start selling a product that already has a CE mark on the EU market after 1 January 2021, there are a few different scenarios. Check out the details below.
Rules for the EU market
If you are a UK-based manufacturer who wants to place a product on the EU market and that product has been CE certified before 1 January 2021, no action is required for:
- Products using self-certification
- Products certified by an EU-27 Notified Body
If you have had a CE mark placed by a UK Notified Body before 1 January 2021 and you have had the existing files transferred to an EU-27 Notified Body before the end of 2020, your existing CE mark is still valid and no further action is required.
If you have had a CE mark placed by a UK Notified Body before 1 January 2021 and you have not had your documents transferred to an EU Notified Body, you must arrange for a new assessment to be carried out by an EU-27 Notified Body.
Rules for the NI market
According to The Northern Ireland Protocol, effective from January 2021, Northern Ireland will comply with the EU rules of placing manufactured goods on the market outlined above. This only relates to a set of products referred to as new approach goods and outlined by the new European legislative framework.
In some cases, a UKNI marking will be required alongside the CE marking. This applies only to products sold on the NI market, which require a mandatory conformity assessment to be carried out by a third party and the third-party assessor you have chosen is a UK body.
UKNI markings cannot be used on their own.
What products are covered by the CE certifications rules?
Brexit has not had an impact on the type of goods that require CE marking in the EU and a minimal impact on the list of products for the NI market.
Rules for the EU market
In 2008, the EU introduced a new legislative framework to improve the quality of products placed in the Common European Market. The goods covered by this legislation are referred to as new approach goods and they require CE certification.
New approach goods include (but are not limited to):
- Low-voltage electrical equipment
- Radio Equipment
- Pressure Equipment
- Medical devices
- Cableway installations
- Marine equipment
- In-vitro diagnostic devices and EU fertilisation products
According to the relevant European standards, new approach goods may also require additional certification, depending on the type of product.
Different rules apply to:
- Old approach goods, such as chemicals, vehicles and medicine
- Non-harmonised goods covered by the specific national legislation of each EU or EEA country. Usually, you only need to conform to rules in the first EU or EEA market country you place non-harmonised goods in.
Rules for the NI market
Non-harmonised goods must comply with UK rules, as well as rules specific to NI. Otherwise, the same CE marking rules for the EU market described above apply to new and old goods placed in the NI market with the following exceptions:
Old approach goods
EU rules apply for old approach goods rules sold in NI, excluding aerospace goods which are subject to UK rules.
New approach goods
EU rules are shared in relation to all new approach goods, except construction products, medical devices, civil explosives, rail interoperability constituents, fertilisers, cosmetics, tobacco products and products requiring ecodesign and energy labelling.
Who is responsible for CE mark certification
The main responsibility for ensuring conformity with the CE-related standards and regulations lies with the manufacturer. However, importers, distributors and fulfilment service providers also share some responsibility.
Ultimately, the manufacturer is responsible for the CE compliance of a product and for providing all the legally required technical documentation, including an EU declaration of conformity. These duties include:
- Implementing the correct conformity assessment procedures
- Placing the CE mark in a way that makes it legible and visible
- Listing the name and address of both the manufacturer (or their representative)
- Listing the details of the EU importer/distributors (if applicable)
- Providing all necessary technical documentation
- Completing an EU Declaration of Conformity
Importers and EU-based distributors must make sure that the manufacturer has completed the duties outlined above and the product is accompanied by instructions for use in the language of the country it’s marketed to.
Fulfilment service providers
New compliance responsibilities may be required from 16 July 2021, however, the new rules haven’t been outlined yet at the time of writing this article.
Both the manufacturer and the importer/distributor must keep a copy of the EU Declaration of Conformity and all other technical documentation from the CE marking process for up to 10 years after the product has been placed on the market. This documentation can be requested by market surveillance and enforcement authorities at any point within the 10-year period.
How to obtain CE mark certification
If you are a manufacturer in the UK who wants to place products on the EU or NI market from 1 January 2021 onwards, you must continue to follow the established CE mark process:
- Ensure your product complies with the relevant EU requirements
- Determine if your product meets the criteria for CE self-certification or if you need to involve a third party
- Collect all required technical information
- Draw up and sign an EU Declaration of Conformity
What should be included in the EU Declaration of Conformity?
The EU Declaration of Conformity indicates that you, as a manufacturer (or your authorised representative), acknowledge your responsibility for the compliance of your product with the EU statutory standards.
The declaration must include key information, such as:
- The product identification number
- The name and full address of the manufacturer or his representative
- A statement of responsibility for the issuing of the CE mark
- The legislation the product complies with
- All technical standards and specifications the product complies with
- Third-party name and identification (if you use a notified body)
- Signature of a representative of the organisation placing your product on the EU/EEA market
- The date the declaration was signed
Remember to keep a copy of the EU Declaration of Conformity for up to 10 years of placing the product of the market, as you may be required to show it the relevant market authorities during an inspection of your CE certification.
How can RiskMach help?
RiskMach offers a comprehensive CE and UKCA self-certification software that ensures you, as a manufacturer, have compiled with the EU legislation and have placed the CE marking correctly. With our collaborative Cloud environment, you can organise your self-certification project and ensure a conformity assessment is carried out correctly. It also allows you to collect all relevant data and keep all documentation in your technical file safe for at least 10 years.