The CE mark shows that a product meets every EU law that applies to it: safety, health, EMC and environmental. It is required before electrical equipment, machinery, toys, construction products, PPE, medical devices and many other goods can be sold anywhere in the EU/EEA. Global Approbation helps Indian manufacturers identify the right directives, test to EN standards, and build a technical file that holds up to customs and market-surveillance checks.
CE Marking at a Glance
| Legal basis | EU New Legislative Framework (Regulation (EC) 765/2008, Decision 768/2008/EC) plus product-specific directives and regulations |
|---|---|
| Common directives | Low Voltage 2014/35/EU · EMC 2014/30/EU · Radio Equipment 2014/53/EU · Machinery 2006/42/EC · Toy Safety 2009/48/EC · RoHS 2011/65/EU · PPE (EU) 2016/425 · Medical Devices (EU) 2017/745 |
| Who assesses | The manufacturer (self-declaration) for many products; a Notified Body for higher-risk products and certain conformity modules |
| Key documents | Technical file (kept for 10 years after the last unit is placed on the market) and EU Declaration of Conformity |
| EU presence | Name and address of the EU economic operator on the product, packaging or accompanying document, as required by Regulation (EU) 2019/1020 |
Products Covered
- Household and kitchen appliances
- IT, AV and office equipment
- Chargers, adapters and power supplies
- LED lighting and luminaires
- Switchgear, cables and wiring accessories
- Industrial machinery and pumps
- Toys and children’s products
- Personal protective equipment
How Global Approbation Handles CE Marking
- Directive mapping. Every applicable directive or regulation and harmonised EN standard identified.
- Conformity route. Self-declaration or Notified Body module selected and documented.
- Testing. Safety, EMC and other tests at accredited labs; existing CB/IEC/BIS data reused where EN standards align.
- Technical file. Risk assessment, test reports, drawings, BOM, user manual in the required language(s), and labels.
- Declaration & marking. EU DoC drafted for your signature, CE mark artwork, and EU representative details added.
Documents Checklist
- Product description, ratings and model variants
- Circuit diagrams, drawings and critical component list
- Existing test reports (CB, IEC, BIS, others)
- User manual and safety instructions
- Label and packaging artwork
- EU importer / authorised representative details
CE Marking: Frequently Asked Questions
Can I self-declare CE marking?
For many products, yes. Under LVD and EMC, for example, the manufacturer tests the product, compiles the technical file and signs the EU Declaration of Conformity. But higher-risk products, and some routes under RED, Machinery, PPE, Toys and Medical Devices, require a Notified Body.
What is the General Product Safety Regulation (GPSR)?
Regulation (EU) 2023/988 has applied since 13 December 2024. It sets safety, traceability and responsible-person obligations for consumer products, including online sales, and applies alongside CE directives or as a safety net where no specific directive exists.
Is a CB report accepted for CE marking?
A CB test report to the IEC standard is widely used as evidence for the equivalent EN standard, provided European differences are covered. It can greatly reduce new testing.
What happens if my product has no valid CE marking?
Market-surveillance and customs authorities can hold shipments, order withdrawal or recall, and impose penalties. Marketplaces like Amazon EU may also delist products without compliant documentation.
Regulations, standards and deadlines change. Scope, testing route and timelines are confirmed product by product after our applicability review. Global Approbation is a consultancy and does not itself issue certificates; approvals are granted by the relevant authority, accredited laboratory, certification body or notified body.