Many export factories think CE is a physical certificate issued by the EU – that can be used directly for customs clearance. In reality, most CE is self‑declaration – the company proves compliance with EU directives and affixes the CE mark – the EU does not issue a certificate – the core document is the DoC.

Only high‑risk categories require NB‑issued certificates. Customs, cross‑border platforms, and market‑surveillance checks focus on the full technical file. Even with the CE mark on the product – without complete documentation – the product is non‑compliant.

1. CE Certification – Required Documents

1.1 Product identification documents

·Product description, full model number, and variants – with intended use and specifications.

·General assembly drawings, schematics, PCB layout – with key components clearly marked.

·BOM: component models and supplier information.

·Certificates for critical components (power supplies, wireless modules).

This is the foundation of the technical file. Model, hardware version, and software version must all align – one mismatch and the entire file must be reworked.

1.2 Risk and test documents

·Risk analysis: MDR (medical) and PPE (personal protective equipment) directives require standalone risk‑assessment reports. For ordinary LVD and RED products, risk analysis can be integrated into the technical file – no separate report needed.

·Test reports:

• Wireless: RF, EMC, safety, SAR.

• Ordinary electronics: LVD and EMC reports.

• Reports must be from ILAC‑accredited labs.

·If an NB is involved: include the NB certificate and type‑examination report.

RED, LVD, and RoHS cover different areas – one report cannot satisfy all directives.

1.3 User and declaration documents

·User manual: must be in EU local languages – safety warnings must be localised – not just English.

·DoC: clearly list applicable directives and harmonised standards – manufacturer and EU representative details complete. Electronic signatures are accepted – paper signatures are not mandatory.

·Economic operator information: manufacturer, importer, EU‑REP – can be on the product, outer packaging, or accompanying documents – not necessarily engraved on the product body.

DoCs are prone to missing items – don't blindly copy online templates – check every item against the actual product.

  2. Different Directives – Different Emphasis

Directive                            Focus

RED                  RF performance – EN 18031 published 2025 – mandatory from 1 August 2027 (not yet mandatory)

LVD                         Insulation, safety

MDR                          Clinical data

PPE                     Product performance

For products subject to multiple directives, organise documents separately – cross‑referencing where needed – don't pile everything into one file.

  3. How Long to Keep Documents

Technical files must be retained for 10 years from the date the last product batch was placed on the market – ready for regulatory audit at any time.

Many companies delete files after certification – years later, market surveillance requests documents – and they can't produce them – leading to penalties. Archive electronically.

  4. Three Most Common Traps

·Safety warnings in the manual not translated into EU languages.

·Missing EU‑REP information.

·Test reports referencing obsolete standard versions.

These are detail oversights – not technical challenges – but they frequently cause product detention.

  5. DoC – Mandatory Elements

A valid DoC must include:

·Product unique identifier.

·Applicable EU directives.

·Harmonised standard numbers.

·Manufacturer and EU‑REP addresses.

·NB information (if applicable).

·Signatory's title, place, and date of issue.

Missing any one → declaration invalid.

  6. EU‑REP – A Hard Requirement

Non‑EU companies exporting to the EU must have an EU Authorised Representative (EU‑REP) – to receive regulatory notifications.

When selecting an EU‑REP, don't just compare annual fees – confirm they can respond to market‑surveillance inquiries – otherwise you'll have no point of contact when issues arise.

  7. CE Mark – Rules

·Standard minimum height: 5mm – for very small products, may be proportionally reduced – no stretching.

·If an NB is involved, the NB number must appear next to the mark.

·"China Export" is an industry colloquialism – not an EU definition – that mark cannot substitute for CE.

  8. Multi‑Directive Example

Take a Bluetooth‑enabled home medical testing device – it must comply with RED, MDR, and RoHS. Each technical file has different focus – product descriptions can be cross‑referenced – reducing duplicate writing. Identifying applicable directives upfront saves document workload.

  9. RoHS and REACH – Don't Miss Them

Electrical/electronic products must comply with RoHS (hazardous substances). Some products also need REACH (chemicals) documentation.

RoHS compliance does not only require test reports – supply‑chain declarations and material exemptions are also valid – all must be in the technical file.

  10. NANDO System – What It Does

NANDO only lists NB body qualifications – it does not list specific product CE certificates.

DoC self‑declaration files are held by the company – when audited, you must produce them quickly. Back up properly – prevent loss when staff leave.

  11. Changes and Templates

Hardware or firmware changes – the technical file must be updated – old files cannot be used for modified products.

Using a checklist template reduces missing items and improves document‑preparation efficiency.

For CE certification documentation, contact BlueAsia at 13534225140 (King) or email king.guo@cblueasia.com.