What does your life sciences company need to market medical devices in the EU and the UK?

The CE and UKCA marks and standards are your medical device’s passport to Europe. But what could their approval actually represent a technical barrier to trade?

Companies willing to expand abroad have to comply with specific international trade regulations and restrictions that might depend on the sector or on the type of product that is marketed. If you want to promote your products in Europe and the UK, you would definitely have to make sure they are CE- and UKCA-compliant and would have to get the respective marking. The letters, “CE”, French for “Conformité Européenne” (European Conformity), are a guarantee that products in the EEA market have been assessed to meet high safety, health, and environmental protection requirements. The UKCA mark (UK Conformity Assessed) is the new product marking for the UK market since Brexit, and it will permanently replace the European CE marking in the UK as from 1 January 2023. But what does all this have to do with product marketing and translations?

International trade restrictions: what is the CE mark?

All manufacturers wanting to sell products in the European Economic Area need to obtain the CE mark for those products so that they can be sold freely in EU markets. The CE mark, despite often being seen as a quality mark, is actually a safety mark guaranteeing that industrial products comply with EU laws after having been assessed through a number of requirements (such as health and environmental protection).

Importing goods to the UK: what is the UKCA mark?

Despite the fact that the UK and the EU have reached some agreements related to trade, product marketing now depends on a new process if you want to import into the UK (particularly to Scotland, Wales, and England, given that Northern Ireland continues to require the CE mark).

Since 1 January 2021, the UKCA mark has taken over the CE mark, although we are still within the transition period, meaning that the CE mark is still acceptable as an alternative to the UKCA. After an initial deadline for the UKCA mark to be fully compulsory as from 1 January 2023, the deadline has been extended to 31 December 2024:

• Products that require the involvement of a third party as a part of their CE marking process will have to use a UK Approved Body;
• Manufacturers based in Great Britain will need a representative based in the EU whose details can go on the product as a contact point for Market Surveillance Authorities;
• Manufacturers based outside the UK and selling within the UK will need a UK-based representative.

If you’d like to learn more, take a look at our blog.

Importing to the UK and the EU: how do companies obtain the CE/UKCA marks?

The process of getting either the CE or the UKCA mark is based on declaring conformity with all the stipulated requirements. A license is not necessary, but companies wanting to market their products will need to:

• Ensure conformity with all the relevant EU/UK requirements
• Have a notified body assess the product
• Have technical documentation related to conformity
• Draft and sign a conformity declaration
• Provide multilingual documentation of the marking after conformity is obtained

What products necessarily require the CA/UKCA marks?

Different product categories require marking, such as medical devices, personal protective equipment, toys, and electric and electronic equipment, to name just a few. Consult these links to learn more:

• Products that require the UKCA mark
• Products that require the CE mark

Official document translation: what are the requirements for the CE/UKCA marks?

The official language in the UK is English, but if you want to market throughout Europe, the CE marking and related documents have to be translated into the official languages of each specific EU member country. For example, for products sold in France, the CE marking must be translated into French. If a manufacturer sells products in Belgium, they have to translate it into German, Dutch, and French.

Importing countries must receive translations of the following:

• Product documentation and materials related to product safety
• User manuals
• Packaging
• Instructions for use of the product
• Labelling
• User interface
• Marketing materials
• Guidelines for users/caregivers

Specifically, the following content groups will have to be translated:

1. Declaration of conformity. This is conformity with the various directives, such as Machinery, Low Voltage, EMC, ATEX, Radio Equipment, Pressure Equipment, Medical Devices, and RoHS.
2. Maintenance and operations manuals. For all products that fall under the directives mentioned above.
3. Technical files.

Don’t miss out on the opportunity to get your products established in a broad and stable market such as the European market: count on us. CPSL is your reliable partner for the entire process: from CE/UKCA marking to compliance for export to the EU.