Drugdu.com expert's response:

When applying for the EU CE certification, the following considerations should be taken into account to ensure a smooth process and compliance with regulatory requirements:

I. Clarify the Scope of Certification and Applicability of Directives

Confirm Whether the Product Requires CE Certification: Not all products require CE certification. Only those products that fall within the scope of the EU "CE Directives" or "Regulations" must undergo certification and affix the CE mark. Currently, the EU has issued more than 20 CE-related directives, covering common categories such as electronics and electrical appliances, machinery, medical devices, toys, and building materials.

Determine Applicable Directives and Standards: Match the corresponding EU directives (such as the Low Voltage Directive, Electromagnetic Compatibility Directive, Medical Device Regulation, etc.) based on the product type, and verify the latest harmonized standards (such as EN 60335-1 for household appliance safety standards). Avoid invalid certification due to incorrect directive selection.

II. Prepare Complete Technical Documentation

Content of Technical Documentation: Technical documentation is the core basis for CE certification review and should include basic product information (such as name, model, specifications, photos, structural diagrams, etc.), a list of components (indicating the model, supplier, and compliance certificates of key components), compliance proof materials (such as risk analysis reports, test reports, declarations of conformity, etc.), production and quality control documents (such as production process flows, quality inspection standards, etc.), and user documentation (multilingual versions of product manuals containing safety warnings, usage instructions, maintenance instructions, etc.).

Requirements for Technical Documentation: The technical documentation should be detailed, accurate, and meet the requirements of the applicable directives. The documents must be retained for at least 10 years for inspection by EU regulatory authorities. If the documents are missing, incorrect, or do not comply with EU format requirements, the certification body will require repeated revisions, severely delaying the process.

III. Select the Appropriate Certification Mode and Institution

Certification Mode Selection: Choose the appropriate certification mode based on the product's risk level. Low-risk products can be self-declared by the enterprise; high-risk products (such as dangerous machinery, Class IIb and above medical devices, etc.) require the involvement of an EU-recognized Notified Body (NB) for certification.

Certification Institution Selection: Select a certified and experienced certification body or third-party laboratory for testing and certification. Avoid choosing unqualified institutions to prevent invalid certification. Make a more informed choice by querying the institution's historical records, customer evaluations, and industry recognition.

IV. Ensure Product Testing Passes

Testing Items: The product must pass a series of tests to verify its compliance with the requirements of relevant directives and standards. Testing items may involve electrical safety, electromagnetic compatibility, mechanical safety, chemical substance detection, etc.

Testing Rectification: If the sample fails any test items, the laboratory will issue a non-conformance report. The enterprise must make product design or process modifications according to the report requirements and resubmit the sample for testing after rectification. It is recommended that enterprises follow up on the testing progress throughout the process and promptly address rectification needs to shorten the testing cycle.

V. Use the CE Mark Correctly

Mark Affixing Requirements: After completing the declaration of conformity, the CE mark can be affixed to a prominent position on the product. The affixing requirements must strictly comply with the corresponding directives: the mark must be clear, durable, identifiable, and no less than 5mm in size. Some directives (such as the MDR Medical Device Regulation) require the simultaneous labeling of the Notified Body code (if applicable).

Mark Usage Specifications: It is prohibited to affix the CE mark before completing the certification process to avoid penalties from market regulatory authorities due to non-compliant labeling. The affixing of the CE mark on a product indicates that the product complies with all the necessary conditions related to the CE mark issued by the EU and can be freely circulated in the EU market.

VI. Strengthen Subsequent Supervision and Maintenance

Technical Documentation Retention: Ensure that the technical documentation is complete and accessible to respond to inspections by EU member state regulatory authorities.

Product Consistency Control: The production process and key components must remain consistent with those at the time of certification. If any changes occur, the conformity must be reassessed, and the test report and declaration of conformity must be updated if necessary.

Regulatory Update Tracking: Stay informed of updates to relevant EU directives and standards to ensure that the product continues to comply with the latest requirements. Avoid certification invalidation due to regulatory iterations.