Lawful market access
Products can be placed on the EU and EEA market with the right evidence.
Product conformity support
CE Marking
EU product conformity
CE marking shows that a product meets the EU legislation that applies to it. We help manufacturers identify the applicable requirements, build the technical documentation and prepare for any notified body assessment.
2027Machinery
The EU Machinery Regulation applies from 20 January 2027
Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC from 20 January 2027. Manufacturers placing machinery on the EU market should review their technical documentation, risk assessment and conformity assessment route before that date.
How CE marking works
From legislation to marking
CE marking is not a single standard. It is a process set by the EU legislation that applies to your product, and the evidence must hold up to market surveillance authorities.
Applicable legislation
Identify every EU regulation and directive that applies to the product.
Harmonised standards
Select harmonised standards that give a presumption of conformity.
Conformity route
Determine whether self-declaration is allowed or a notified body is required.
Risk assessment
Identify hazards and show how essential requirements are met.
Testing
Plan testing with competent, ideally accredited, laboratories.
Technical documentation
Compile the technical file that supports your declaration.
Declaration of conformity
Draw up and sign the EU Declaration of Conformity.
Ongoing conformity
Keep production consistent and files current as products and rules change.
Why organisations implement it
What a sound CE process delivers
Fewer surprises
Technical files ready for market surveillance requests and customer checks.
Faster notified body review
Complete, well-organised submissions where assessment is required.
Controlled design change
A process that keeps conformity intact when products change.
Quality system link
Production control tied to ISO 9001 or ISO 13485 where they apply.
Clear responsibilities
Manufacturer, importer and distributor duties understood and assigned.
How we work
Path to CE marking
One AEC methodology from first assessment to declaration of conformity, delivered by registered lead auditors.
- AssessProduct, legislation and current evidence reviewed against requirements
- DesignConformity route, standards list and documentation plan agreed
- ImplementRisk assessment, design measures and production controls in place
- TrainEngineering and quality teams briefed on their CE responsibilities
- VerifyTechnical file review and test evidence checked for gaps
- Declare & sustainDeclaration of conformity, notified body support where required, upkeep
First CE marking
We take the product from requirements to declaration of conformity.
Typically 3 to 6 monthsTechnical file remediation
We close gaps in documentation and evidence for products already on the market.
Typically 1 to 3 monthsLegislation transition
We update files and conformity routes when legislation changes, such as machinery from 2027.
Typically 1 to 3 months
Who decides
Notified bodies and manufacturer responsibility
Where the legislation requires third-party assessment, it is performed by a notified body designated by an EU member state. Otherwise the manufacturer declares conformity on its own responsibility. AEC prepares your evidence; it does not issue CE certificates or act as a notified body.
Independent
We help you identify and engage a notified body suited to your product where one is required.
Evidence-ready
Technical file review and gap closure before submission.
No guarantees
We prepare you thoroughly and never promise an outcome only a notified body or authority can decide.
Where it applies
CE Marking by industry
Manufacturing · machinery and electrical equipment
Healthcare · medical devices under EU MDR
Construction · construction products
IT services · connected and radio equipment
Related standards
Questions
CE Marking FAQ
Does AEC issue CE certificates?
No. AEC is not a notified body. Where the legislation requires third-party assessment, a notified body performs it. Otherwise the manufacturer declares conformity. AEC prepares the evidence for either route.
Do we need a notified body?
It depends on the legislation and the product's risk. Some products can be self-declared; others, such as many medical devices and certain machinery, require notified body involvement. We confirm your route at the start.
What goes into a technical file?
Typically a product description, the applicable legislation and standards, risk assessment, design and manufacturing information, test reports, instructions and the EU Declaration of Conformity. The exact content is set by each piece of legislation.
How does CE marking relate to ISO 9001 or ISO 13485?
CE marking concerns product conformity. A quality management system supports consistent production and, for some routes and products, is part of the notified body assessment. We align both where they apply.
Prepare your products for CE marking
Tell us your products, target markets and current documentation. We reply with a proposal covering legislation review, technical files and notified body readiness.
Where third-party assessment is required, decisions are made by notified bodies designated by EU member states. AEC prepares organisations for conformity assessment and does not guarantee outcomes.