Product Certification
CE Marking Assistance
The technical route to placing your product legally on the EU market.
Why organisations certify
Key benefits of CE Marking Assistance
What certification actually returns, stated specifically rather than generically.
Credibility
A correctly compiled technical file is the difference between a defensible conformity claim and an assertion that fails at the first market surveillance inspection.
Market Access
CE marking is a legal precondition for placing a product on the EU and EEA market — without it there is no market at all.
Risk Reduction
Correct legislation mapping prevents the most expensive CE failure: a compliant product marked under the wrong instrument.
Operational Efficiency
Identifying the right harmonised standards early avoids duplicate and misdirected testing spend.
Customer Trust
EU distributors and importers routinely audit technical files before taking a product; a complete file shortens onboarding.
Regulatory Compliance
Supports obligations under the EU Machinery Regulation, LVD, EMC, RoHS, REACH, MDR, IVDR, PPE and CPR as applicable.
How it works
Our process for CE Marking Assistance
Every stage has a defined purpose, a realistic duration and a stated output.
- 01
Product & Legislation Scoping
1 week
We determine every EU directive and regulation applicable to the product, its intended use and its foreseeable misuse.
- 02
Standards & Module Selection
1–2 weeks
Applicable harmonised standards are identified and the correct conformity assessment module selected — including whether a Notified Body is mandatory.
- 03
Gap Assessment & Testing
3–8 weeks
The product and its documentation are assessed against the standards; required testing is scoped and coordinated with accredited laboratories.
- 04
Technical File & Declaration
2–3 weeks
The technical file is compiled — risk assessment, design documentation, test reports, instructions — and the EU Declaration of Conformity prepared for your signature.
Preparation
Documents required
What we will ask to see. Having these ready before Stage 1 is the single biggest factor in a certification that runs to schedule.
- Product technical specification, drawings and bill of materials
- Intended use statement and foreseeable misuse analysis
- Risk assessment per the applicable harmonised standard
- Design calculations and material certificates
- Test reports from accredited laboratories
- User instructions, installation and maintenance manuals in required languages
- Component supplier declarations of conformity
- Manufacturing quality control procedures
Not sure whether your scope is right?
Scope is the single thing most often got wrong, and it appears verbatim on your certificate. We will review yours before you apply, at no charge — it costs us less than fixing it at recertification.
Talk to a specialistOften certified together
Related standards
Standards sharing the High Level Structure can be operated as one integrated system and audited together, which reduces total audit days.
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Learn moreCommon questions
CE Marking Assistance — frequently asked questions
Direct answers, including where the honest answer is inconvenient for us.
For most product categories there is no CE certificate to issue — CE marking is a self-declaration by the manufacturer, supported by a technical file. Where the applicable legislation mandates third-party assessment, that must be performed by an EU-designated Notified Body. Our role is to prepare you correctly for either route.
CE marking has no expiry date, but the declaration must remain accurate. Any change to the product, to the applicable legislation, or to the harmonised standards may require reassessment and an updated technical file and Declaration of Conformity.
Question not answered here? Ask a certification specialist — we answer technical questions without requiring an enquiry first.
Talk to us
Talk to a certification expert
Tell us your scope and headcount and we will send a fixed quotation for CE Marking Assistance with the audit-day calculation shown.
- Quotation within 2–3 working days
- IAF MD 5 audit-day calculation included
- Full three-year cycle cost, not just the first audit
- Your details are used only to answer this enquiry
Next step
Ready to certify to CE Marking Assistance?
We will scope it honestly, show you the calculation behind the price, and tell you plainly if the timeline you need is not achievable.