CE marking is the manufacturer's declaration that a product meets the applicable EU health, safety and environmental requirements. It is mandatory for products covered by certain EU directives and allows free movement within the European Economic Area.

When do I need a Notified Body?

A Notified Body is required when a directive mandates third-party conformity assessment, typically for higher-risk products such as most medical devices, pressure equipment and certain machinery and PPE categories. Lower-risk products can use self-assessment with internal production control.

Can one product fall under several directives?

Yes. A product often must comply with multiple directives simultaneously — for example a mains-powered radio toy may fall under the Toy Safety, EMC, Radio Equipment and RoHS rules at once. The CE mark covers all of them together.

What is a Declaration of Conformity?

The EU Declaration of Conformity is a legally required document in which the manufacturer states the product meets all applicable directives, lists the standards applied, and identifies the manufacturer. It must be kept and made available to authorities on request.

Is my selection sent anywhere?

No. The decision tree runs entirely in your browser using a built-in mapping of categories to directives. Nothing about your product is transmitted or stored.

CE Marking Decision Tree

CE marking signals that a product meets the EU’s health, safety and environmental requirements and may move freely across the European Economic Area. The hard part is figuring out which directives apply and whether you can self-declare or must involve a Notified Body. This free decision tree maps your product category to the relevant EU legislation, summarises the essential requirements and flags the conformity route. It is built for manufacturers, importers and product-compliance teams.

How it works

CE marking is directive-driven, not product-driven: you identify every “New Approach” directive or regulation whose scope your product falls within, then satisfy each one’s essential requirements. The tool encodes the common mappings:

Electrical equipment → Low Voltage Directive (2014/35/EU) and EMC Directive (2014/30/EU); self-declaration with internal production control.
Machinery → Machinery Regulation (EU) 2023/1230; most machinery self-declares, but Annex I high-risk machines need a Notified Body.
Medical devices → Medical Device Regulation (EU) 2017/745; Class I self-declares, Class IIa and above require a Notified Body.
Toys → Toy Safety Directive (2009/48/EC); self-declaration unless no harmonised standard applies, then EU-type examination.
PPE → PPE Regulation (EU) 2016/425; Category I self-declares, Categories II and III require a Notified Body.
Radio equipment → Radio Equipment Directive (2014/53/EU) plus EMC; Notified Body only where harmonised standards are not fully applied.
Construction products → Construction Products Regulation (EU) 305/2011; Declaration of Performance and CE mark via the relevant Assessment and Verification of Constancy of Performance system.

For each match the tool tells you whether a Notified Body is typically required so you can scope cost and lead time early.

Notes and example

A mains-powered remote-control toy car falls under Toy Safety, LVD, EMC, the Radio Equipment Directive and RoHS at once — five sets of essential requirements under a single CE mark and one Declaration of Conformity. A Class IIb implantable medical device requires a Notified Body, an audited quality system and ongoing post-market surveillance.

The tool gives directive-level guidance, not a substitute for the directive text or a conformity-assessment body. Always confirm your product’s exact classification. Everything is computed locally.