Product Categories
Requirements by product category
Understand compliance requirements for your specific product type
The EU Toy Safety Directive ensures toys sold in the EU meet strict safety, chemical, mechanical, electrical, and labeling standards.
Testing: Mechanical/physical safety, chemical content, flammability, electrical safety
Notified Body: Most toys allow manufacturer self-declaration
Documents: Technical File, Risk Assessment, Instructions, test reports, Declaration of Conformity, CE marking
The EU Medical Device Regulation ensures that medical devices sold in the EU meet strict safety, performance, and quality standards.
Testing: Biocompatibility, electrical/mechanical safety, performance, clinical evaluations
Notified Body: Required for Class IIa, IIb, III; Class I can be self-certified
Documents: Technical File, Risk Management File, Clinical Evaluation, Instructions, Declaration of Conformity, CE marking
Electrical & Electronic Products
Must meet safety, electromagnetic compatibility, hazardous substance, and waste management requirements for EU market entry.
Testing: Electrical safety, insulation, EMC, chemical content (RoHS), functional testing
Notified Body: Most low-risk equipment can be self-declared
Documents: Technical File, risk assessment, test reports, instructions, Declaration of Conformity, CE marking
EU regulations for textiles ensure consumer safety, accurate fiber labeling, and restriction of harmful chemicals. CE marking not required.
Testing: Fiber identification, colorfastness, flammability, formaldehyde, heavy metals, REACH chemicals
Notified Body: Not applicable
Documents: Technical File, test reports, fiber composition labels, care instructions, risk assessment
Must meet REACH chemical restrictions, mechanical safety, and general product safety requirements. CE marking not required.
Testing: Restricted substances, heavy metals, phthalates, formaldehyde, flammability, physical strength
Notified Body: Not applicable
Documents: Technical File, test reports, material composition, labeling, risk assessment, traceability
Must comply with REACH restrictions on hazardous chemicals, physical safety standards, and labeling requirements. CE marking not required.
Testing: Chromium VI, formaldehyde, heavy metals, color fastness, tensile strength
Notified Body: Not applicable
Documents: Technical File, test reports, material composition, labeling, risk assessment, traceability
The EU Machinery Directive ensures machines meet essential health, safety, and environmental requirements before market placement.
Testing: Mechanical safety, electrical safety, stability, noise, vibration, protective systems
Notified Body: Most machines allow self-declaration; high-risk machinery may require Notified Body
Documents: Technical File, Risk Assessment, Instructions, operating manuals, Declaration of Conformity, CE marking
The EU Construction Products Regulation ensures that construction products meet essential safety, health, and performance requirements.
Testing: Mechanical strength, fire resistance, thermal/acoustic performance, durability, chemical resistance
Notified Body: Mandatory for high-risk products; some products allow self-declaration
Documents: Declaration of Performance, Technical Documentation, test reports, CE marking
Personal Protective Equipment (PPE)
The PPE Regulation ensures that personal protective equipment meets essential health and safety requirements for market entry.
Testing: Mechanical, chemical, thermal, electrical, ergonomic, biological protection tests
Notified Body: Category I can be self-declared; Category II & III require Notified Body
Documents: Technical File, risk assessment, user instructions, test reports, Declaration of Conformity, CE marking
The EU Pressure Equipment Directive ensures that pressure vessels, piping, and related equipment meet essential safety, design, and manufacturing requirements.
Testing: Hydraulic, pneumatic, mechanical strength, leak, and material integrity tests
Notified Body: Category II, III, IV generally require Notified Body; lower-risk may allow self-declaration
Documents: Technical File, risk assessment, design documentation, test reports, Declaration of Conformity, CE marking
The EU Gas Appliances Directive ensures that gas-fired appliances meet essential safety, performance, and environmental standards.
Testing: Gas tightness, combustion efficiency, flue performance, electrical safety, mechanical stability
Notified Body: High-risk or complex appliances require Notified Body; simpler may allow self-declaration
Documents: Technical File, Risk Assessment, Instructions, test reports, Declaration of Conformity, CE marking
The Simple Pressure Vessels Directive ensures non-complex pressure vessels operate safely under design pressure limits.
Testing: Pressure resistance, material integrity, leak tests, dimensional verification
Notified Body: Mostly self-declared; certain high-risk vessels may require Notified Body
Documents: Technical File, Risk Assessment, design and material documentation, test reports, Declaration of Conformity, CE marking
The Radio Equipment Directive ensures that radio and telecom devices meet essential health, safety, electromagnetic compatibility, and spectrum requirements.
Testing: Electromagnetic compatibility (EMC), radio spectrum efficiency, electrical safety, environmental performance
Notified Body: Most devices allow self-declaration; high-risk or complex may require Notified Body
Documents: Technical File, risk assessment, test reports, user manuals, Declaration of Conformity, CE marking
The EU Cosmetics Regulation ensures that cosmetic products are safe for human use. CE marking is not required for cosmetics.
Testing: Ingredient safety evaluation, microbiological safety, stability, heavy metal limits (animal testing prohibited)
Notified Body: Not applicable
Documents: Product Information File (PIF), safety assessment, formulation, labeling, CPNP notification before market placement
The EU Detergents Regulation ensures that cleaning products are safe, environmentally friendly, and properly labeled. CE marking not required.
Testing: Biodegradability, toxicology, chemical composition, allergen content, pH/skin irritation
Notified Body: Not required
Documents: Product Information File, ingredient list, test results, biodegradability data, labeling compliance, safety information
The Biocidal Products Regulation controls products containing active substances for controlling harmful organisms. CE marking not applicable.
Testing: Toxicology, ecotoxicology, efficacy against target organisms, stability, chemical composition
Notified Body: Not applicable; products must be authorized by ECHA or national authorities
Documents: Dossier with active substance approval, risk assessment, safety data sheets, labeling, instructions, authorizations
Ensures that materials in contact with food are safe, inert, and do not transfer harmful substances. CE marking not required.
Testing: Overall and specific migration tests, compositional analysis, functional safety assessments
Notified Body: Not required
Documents: Technical Documentation File, composition, manufacturing process, safety assessment, migration test reports, labeling, traceability
The CLP Regulation ensures chemicals and mixtures are properly classified, labeled, and packaged to protect human health and the environment.
Testing: Toxicology, ecotoxicology, flammability, reactivity, corrosivity, physical-chemical property testing
Notified Body: Not applicable
Documents: Safety Data Sheet (SDS), classification and labeling documentation, risk assessments, packaging compliance with pictograms
European Union