Service 05 β€” CE Marking

Conformity Strategy & Technical Documentation

We act as your Regulatory Architects. We translate your R&D outputs into a bulletproof Technical Documentation (TD) file, securing your CE marking and ensuring you pass the EU Notified Body examination without delays.

Step 01 β€” EngageBook a Certification Strategy Call
The Hazard

The "Paperwork Afterthought" Trap

Startups often treat EU documentation as an afterthought, compiling test reports at the last minute. This leads to disjointed files, mismatched SKUs, and missing risk assessments. Under the EU Blue Guide and the Radio Equipment Directive (RED), if your Technical Documentation is incomplete, Customs will halt your shipments, and EU Notified Bodies will reject your certification application. We build your legal file iteratively during the R&D phase so you are ready for launch on day one.

What We Offer: Engineering-Driven Compliance

01

Certification Routing (Module A vs. Module B+C)

We define the exact legal pathway to affix the CE marking on your hardware, saving you time and laboratory fees.

  • Module A β€” Internal Production Control

    If your design fully applies EU Harmonised Standards published in the Official Journal (OJEU), we guide your team through the self-assessment procedure without the need for a third-party lab.

  • Module B+C β€” EU-Type Examination

    If your RF integration deviates from Harmonised Standards, or if standards do not exist for your specific technology, EU law strictly mandates the intervention of an independent European Notified Body. We prepare and defend your dossier before the Notified Body to guarantee you pass this strict examination.
02

Technical Documentation (TD) Assembly (RED Annex V)

We compile and review your entire technical file according to Annex V of the RED. We ensure absolute consistency across:

  • Engineering Artefacts

    Block diagrams, schematics, and PCB layouts.

  • Laboratory Evidence

    Laboratory test reports and component declarations.

  • Multi-Directive Risk Assessment

    Covering Health & Safety without voltage limits, EMC, Radio Spectrum, and Cybersecurity.
03

The Single EU Declaration of Conformity (DoC)

  • One Document, All Frameworks

    As the legal Manufacturer, your CEO or authorized representative must sign the DoC, assuming full legal responsibility. We draft your ultimate legal passport: a unified 'Single DoC' that strictly fuses all applicable EU frameworks (RED, CRA, RoHS, Eco-design) into one compliant document.