From electronics to toys, medical devices to machinery, CE marking is your product's passport to the European and UK markets. It's everywhere, and it's essential, but that doesn’t mean that it has to be hard. Whether you’re launching your first product or expanding into new markets, our services simplify the entire process, helping you get and/or maintain the CE and UKCA marking.

“CE marking shows that the product conforms with EU legislation and enables the free movement of products within the European market.”

European Commission

How Obelis Supports Your CE Marking Journey

Manufacturers: What does the law say? 

Since July 2021, with the new regulation 2019/1020/EU (Market Surveillance and Product Conformity) all devices with the CE marking are not allowed to be sold in Europe without an authorized representative based in the EU. The same applies in the UK since the BREXIT. 

What You Need to Know: CE & UKCA Marking

What is CE Marking?

CE marking demonstrates that your product complies with the relevant EU legislation. It shows that your product meets essential health, safety, and environmental standards, allowing it to be freely sold within the European Economic Area (EEA).

• Why You Need CE Marking: Without CE marking, your product cannot be legally placed on the market or sold in the EU.
• Products That Require CE Marking: Medical devices, electronics, toys, machinery, and more.

What is UKCA Marking?

With Brexit, the UK introduced the UKCA (UK Conformity Assessed) marking, which applies to most products placed on the market in Great Britain. While it is similar to CE marking, the process and regulations can differ.

• Why You Need UKCA Marking: UKCA marking is now required for most products sold in England, Scotland, and Wales.
• Products That Require UKCA Marking: The same categories as CE, but also products transitioning post-Brexit.

Obelis: Your trusted partner for CE marking compliance

Obelis is committed to making CE marking straightforward and efficient for businesses. As an Authorized Representative, we work with you every step of the way. From initial conformity assessments to post-market surveillance, we ensure your products meet all EU standards for seamless access to the EEA.

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What are the requirements?

Companies must ensure their CE-marked products continue to meet quality and safety standards and include the contact details of the authorised representative. 

This information can be displayed on the product, its packaging, or accompanying documentation.

Companies are also required to:

• Obtain the declaration of compliance and ensure additional documentation is readily available upon request by authorities.
• Notify authorities about any risks posed by the products in certain situations.
• Cooperate with authorities during market surveillance activities.
• Ensure manufacturers address any non-compliance issues promptly.

Working with an Authorized Representative like Obelis, will simplify all the above requirements and manage your relationship with competent authorities in EU and the UK. 

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