Welcome to CE-Quickie
' BETA TEST *** HERE IS THE TEST SYSTEM *** MORE IS COMING IN NEXT WEEKS ***What CE Marking Is
CE marking is a mandatory indication that a product complies with all applicable EU harmonised product legislation, enabling its free movement within the EU market. It is not a quality seal but a legal requirement for products covered by specific EU rules.
1. EU Conformity Assessment: Core Principles
Purpose A conformity assessment procedure defines the actions a manufacturer must take to demonstrate that a product meets the essential health, safety, and environmental requirements of the relevant EU directive or regulation.
Key Tasks in the Procedure
- Identify applicable EU legislation and harmonised standards
- Determine whether self‑assessment is allowed or a notified body must be involved
- Prepare technical documentation
- Conduct required testing
- Draft and sign the EU Declaration of Conformity (DoC)
- Affix the CE marking to the product
Risk-Based Approach Products with higher risk (e.g., certain PPE, medical devices) require stricter modules and often mandatory involvement of a notified body. Lower‑risk products may allow self‑assessment.
2. Overview of Key EU Directives & Regulations Requiring CE Marking
CE marking applies only to products covered by harmonised EU legislation. Examples include:
- Low Voltage Directive (LVD) – electrical safety for products within defined voltage ranges
- Machinery Directive (MD) – safety requirements for machinery placed on the EU market
- Medical Devices Directive / Regulation – safety and performance of medical devices
- Radio Equipment Directive (RED) – radio spectrum use and related safety requirements
- Additional categories include toys, drones, gas appliances, pressure equipment, PPE, weighing instruments, and more.
Some products fall under multiple directives simultaneously; manufacturers must comply with all applicable requirements before affixing the CE mark.
| name | new | usage | new |
|---|---|---|---|
| Equipment for potentially explosive atmospheres | ATEX | 2014/34/EU | ATEX guideline (German) |
| Your Name | new | For You | new |
3. Responsibilities of Economic Operators
Manufacturer The manufacturer is fully responsible for ensuring compliance and affixing the CE mark, even when components are sourced from others.
Importers & Authorized Representatives They carry specific obligations such as verifying documentation, ensuring correct marking, and cooperating with market surveillance authorities.
4. Affixing the CE Marking
Rules for Placement The CE marking must be visible, legible, and indelible.
It must be affixed before the product is placed on the EU market.
If a notified body is involved, its identification number must accompany the CE mark.
The mark may only be used for products covered by EU legislation requiring CE marking; otherwise, it must not be used.
After Affixing Once the CE mark is applied, the product can circulate freely within the EU. Authorities may still perform compliance checks and request documentation.
5. Summary: The CE Marking Process at a Glance
01 Identify applicable EU legislationDetermine which EU directives or regulations apply to your product and whether CE marking is required. 02 Assess conformity requirementsCheck whether self‑assessment is allowed or if a notified body must be involved based on product risk. 03 Compile technical documentationPrepare evidence such as test reports, risk assessments, and design information demonstrating compliance. 04 Draft the EU Declaration of ConformityFormally declare that the product meets all applicable EU requirements and reference relevant legislation. 05 Affix the CE markingPlace the CE mark visibly and indelibly on the product, adding the notified body number if required.
