CE Compliance Certification (CE Marking)

CE Compliance Certification (CE Marking)

Smooth EU Market Entry | Reduced Liability | Higher Buyer Confidence

CE Marking is mandatory for many regulated products sold in the European Economic Area (EEA). By affixing the CE Mark, the manufacturer declares the product meets applicable EU safety, health, and environmental requirements—supported by technical evidence, risk controls, and a compliant conformity assessment route.

What is CE Marking?

CE = Conformité Européenne (European Conformity).

It indicates that a product has been assessed (by the manufacturer and, where required, a Notified Body) and meets the essential requirements of relevant EU legislation.

Typical outcomes of CE compliance:

  • Legal access to the EU and EEA market
  • Lower product liability and recall risk
  • Stronger distributor and customer trust
  • Better product design discipline through risk-based engineering and documentation

CE Services by Smartedge

1) CE Marking Support (End-to-End)

  • Directive and Regulation applicability assessment
  • Harmonised standards (EN) mapping
  • Conformity route selection including module selection and Notified Body involvement if needed
  • Testing coordination and compliance evidence build-up
  • EU Declaration of Conformity (DoC) preparation support

2) CE Technical File / Technical Documentation Support

  • Technical file structure as per applicable annexes
  • Risk management file including hazard identification, risk estimation, and risk controls
  • Test evidence pack such as type tests, EMC, LVD, and performance testing
  • Labelling, IFU and manuals, warnings, and traceability records
  • Post-market documentation readiness where applicable

3) MDD to MDR Transition (Medical Devices)

  • Gap assessment versus MDR (EU 2017/745)
  • Technical documentation upgrade aligned to Annex II and Annex III
  • Clinical evaluation and PMCF strategy alignment where applicable
  • UDI and traceability readiness
  • Notified Body submission readiness support

Products Commonly Requiring CE Marking

Depending on legislation applicability, CE Marking may apply to categories such as machinery, low voltage equipment, EMC products, PPE, pressure equipment, radio equipment, construction products, medical devices, toys, measuring instruments, and more.

Step-by-step CE Marking Process (Clean Roadmap)

Step 1: Identify Applicable EU Legislation

Not every product needs CE—only those falling under at least one CE regulation or directive.

Step 2: Map Essential Requirements and Harmonised Standards (EN)

Using harmonised standards is a common way to show presumption of conformity.

Step 3: Choose the Conformity Assessment Route

Some products allow self-declaration, while others require a Notified Body depending on product risk and category.

Step 4: Perform Assessment and Testing

Compile objective evidence that requirements are met, such as test reports, calculations, and inspections.

Step 5: Compile Technical Documentation (Technical File)

Maintain the technical file typically for 10 years after the last unit is placed on the market, with exact requirements varying by legislation.

Step 6: Issue Declaration of Conformity and Affix CE Mark

Once complete, you can legally place the product on the EU market.

What Goes Into a Strong CE Technical File (Checklist)

A robust technical file typically includes:

  • Product description and intended use
  • Design drawings, schematics, and bill of materials
  • Risk assessment and risk management documentation
  • Applied standards list including EN, ISO, and IEC
  • Test reports and verification records
  • Critical component compliance evidence
  • User manual or IFU, labels, and warnings
  • EU Declaration of Conformity draft or final

MDR Transition: Correct, Current Position (MDD to MDR)

The MDR (EU 2017/745) has applied since 26 May 2021.

The EU adopted Regulation (EU) 2023/607 to extend transitional provisions for certain legacy devices subject to conditions and removed the sell-off deadline so devices already placed on the market do not face forced withdrawal purely due to time.

The MDR transitional period under Article 120 was extended and will end on 31 December 2027 or 31 December 2028 depending on device risk class and applicable conditions.

Practical takeaway: Many older May 2024 end-date statements are now outdated for several device categories. Transition planning should be done device by device considering class, certificate type, Notified Body status, and technical and clinical evidence readiness.

Why Smartedge

  • Regulation-first approach rather than template-first
  • Strong technical documentation discipline with audit readiness mindset
  • Integration capability with ISO 9001, ISO 13485, and ISO 17025 ecosystems
  • Clear project plan from gap to evidence to file to Declaration of Conformity to CE readiness

Ready-to-use CTA (Website / Brochure)

Planning to export to Europe or upgrade from MDD to MDR?

Smartedge can run a quick applicability and gap check and give you a clear, compliant path to CE Marking—covering technical file preparation, testing evidence, and documentation readiness.