Scope
Regulation (EC) 765/2008 & Decision 768/2008
CE Marking: European Conformity Assessment
CE marking indicates that a product meets EU health, safety, and environmental requirements. It is mandatory for products sold in the European Economic Area across more than 25 EU directives and regulations. The specific tests required depend on the applicable product directive -- from electromagnetic compatibility for electronics to mechanical strength for construction products.
Scope
Mandatory for products covered by EU harmonised legislation, including machinery, electronics, medical devices, construction products, toys, PPE, and many more. Each product category has its own directive with specific testing requirements.
Key Dates
Compliance Timeline
1993-01-01
CE marking system established
2008-08-13
New Legislative Framework adopted
2021-07-16
Updated market surveillance regulation
Testing
Required Test Methods
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FAQ
Frequently Asked Questions
Which products need CE marking?
Products covered by one or more of the 25+ EU directives and regulations that require CE marking. This includes machinery, low-voltage equipment, radio equipment, medical devices, construction products, toys, personal protective equipment, pressure equipment, and more.
What testing is required for CE marking?
The tests depend entirely on which directive applies to your product. Electronics typically need EMC and safety testing. Construction products need fire reaction and mechanical tests. Medical devices need biocompatibility and performance testing. An accredited test laboratory can advise on the applicable standards for your specific product.
Must testing be done by a Notified Body?
Not always. Some product categories allow manufacturer self-declaration (Module A) based on testing by any accredited laboratory. Higher-risk products require third-party conformity assessment by an EU-designated Notified Body. The applicable directive specifies which conformity assessment modules are permitted.
Is CE marking valid in the UK after Brexit?
CE marking is no longer recognised for the GB market (England, Scotland, Wales) -- products need UKCA marking instead. CE marking remains valid for the Northern Ireland market under the Windsor Framework. Products sold in both markets may need both marks.
Related
Related Regulations
This guide is an educational resource to help you understand testing requirements. It does not constitute legal advice. Always consult the official regulation text and qualified legal counsel for compliance decisions.