CE marking · EU product conformity
CE marking compliance support for manufacturers placing products on the EU market.
CE marking shows that a product meets the EU legislation that applies to it. The manufacturer carries out the conformity assessment, prepares the technical documentation, signs the EU declaration of conformity and affixes the marking. Sterling's expert and experienced consultants help you get each step right. We help our clients put it into practice and prove it.
- One all-inclusive proposal: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard
- Expert and experienced consultants who have built quality and compliance systems for manufacturers since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Sterling never affixes the CE marking and is not a notified body
8,100+ client engagements in 60+ countries.
Manufacturing client experience
What it is
What is CE marking?
CE marking is the conformity marking used under EU product legislation. By affixing it, the manufacturer indicates that the product meets the requirements of the EU rules that apply to it, and the product can then circulate in the EU market. The European Commission publishes guidance for manufacturers on the steps involved and on the New Legislative Framework behind them.
CE marking is not a certificate and not a quality mark. It is the manufacturer's statement of compliance, backed by a conformity assessment and technical documentation. For some product types the legislation requires a notified body to take part in the conformity assessment. Sterling helps manufacturers prepare; Sterling never affixes the marking and never acts as a notified body.
Current guidance. The European Commission published the 2022 edition of the Blue Guide on the implementation of EU product rules in June 2022. Sector legislation, such as the Construction Products Regulation, has its own rules and documents.
Who it is for
Who needs CE marking?
Manufacturers, importers and brand owners come to CE marking from one of four starting points:
- You are launching a product in the EU. You need to know which legislation applies and what evidence it expects.
- A distributor or importer asks for the file. They want the declaration of conformity and technical documentation before they list your product.
- Your product or the rules have changed. A redesign, new component or new regulation means the assessment must be revisited.
- You make products outside Europe. Exporters need an EU-ready file and a clear view of who holds which responsibility.
The obligation sits with the economic operator; our work gives you the evidence to meet it with confidence.
Requirements
What does CE marking require?
The European Commission's guidance for manufacturers sets out the core steps below. The detailed requirements differ by product legislation and are confirmed for your product at the start.
- Applicable legislation: identify the EU product rules that cover the product
- Conformity assessment: carry out the procedure the legislation sets, with a notified body where it is required
- Technical documentation: prepare the file that shows how the product meets the requirements
- EU declaration of conformity: draw up and sign the declaration
- CE marking: affix the marking once the steps above are complete
What does a useful CE technical file look like?
A clear product description, the legislation and requirements identified, design and risk records, test reports from competent laboratories, production control records and the signed declaration. Kept current in Effivity, the file is ready when an importer, customer or market surveillance authority asks.
Your engagement
What your CE marking engagement includes
Your agreed scope brings together what your team needs to meet CE requirements and keep the evidence current, from one team under one all-inclusive proposal.
Applicability review and plan
Products, legislation and responsibilities agreed, with owners and dates.
Technical documentation support
The file structured and completed with your engineers.
Effivity ISO & GRC software
Documents, changes and records in one workspace, included at no additional cost.
Training for everyone
Preferential Sterling Academy access, including complimentary awareness training for your people.
Quality system support
Production control and, where relevant, an ISO 9001 or ISO 13485 system to support conformity.
Readiness support
Preparation for notified body involvement where the legislation requires it.
Sterling never affixes the CE marking and is not a notified body. The manufacturer declares conformity and remains responsible; where a notified body is involved, it makes its own decision.
Often combined with
Standards organisations pair with CE marking
- EN 1090EN 1090 certification for steel and aluminium fabricators: factory production control, welding, execution records and support through the notified body's audit.
- EN 71 / ASTM F963EN 71 and ASTM F963 toy safety compliance for manufacturers: product and market mapping, material control, test planning and records that keep lots conforming.
- EU Cyber Resilience ActCyber Resilience Act compliance and requirements for products with digital elements: categories, reporting since September 2026 and CE marking by December 2027.
- EU MDR 2017/745EU MDR compliance consulting for CE marking: QMS, technical documentation, traceability and post-market surveillance prepared for your notified body.
- IEC 61508IEC 61508 compliance support for E/E/PE safety-related systems: functional safety management, lifecycle records, SIL evidence and assessment readiness.
- IEC 61511IEC 61511 compliance for process plants: the safety instrumented system lifecycle, functional safety management and the evidence your assessors expect.
Effivity · ISO and GRC software, included in every engagement
How Effivity helps you fulfil, automate and simplify the requirements of CE marking.
Every Sterling CE marking engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant configures the workspace within the agreed scope, so technical files, design changes, supplier records, test reports, complaints and corrective actions live in one place, the system runs in daily work and an importer, customer or notified body reviews a live system rather than a binder. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.
Scope and interested parties
The scope, the internal and external issues and the interested parties are kept in one register and reviewed on a schedule, so they stay current as the business changes instead of being rewritten before each assessment.
Policies, roles and objectives
Policies, responsibilities and objectives with their measures, owners and dates live where the people who own them work; progress is reported from the system, not from a separate spreadsheet.
Risks and opportunities
A risk register with owners, actions and review dates; treatments tracked to closure and brought to management review automatically.
Competence, awareness and documented information
Training and competence records for every person, linked to Sterling Academy; documents with versions, approvals and distribution, so the current version is the only one in use.
Design, change control and production
Design records, change control, supplier evaluation, inspection and release, each with its record created as the work is done.
Monitoring, internal audit and management review
Audit programmes, findings and follow-up; KPIs on live dashboards; a management review that records its inputs, decisions and actions.
Nonconformity, complaints and corrective action
Raised, investigated and closed with root cause and the evidence that the action worked; recurring issues visible to management before they become a finding.
Your own processes, forms and reports
Forms, fields, workflows and reports adapted to how you work, without code; legal and customer requirements tracked to the processes they affect.
What this means at a file review
An importer, customer or notified body asks for the technical file, the declaration, test reports and change history. In Effivity each is a screen with dates, owners and evidence attached. After launch, Sustain™ keeps the file current as products and rules change.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Your documents, records and registers migrated, not retyped
- Admin and user training for your team
- Modules for QMS, EMS, OHSMS, ISMS and more when you integrate other standards
Sterling Academy · CE marking e-learning
Train your engineers and production team, not just the compliance lead.
Sterling Academy delivers e-learning for the whole workforce and for the people who run the system: video lessons with practice checkpoints, a final exam and a numbered Certificate of Completion for each learner, verifiable online. Sterling consulting clients benefit from preferential course access and special pricing through their Sterling consultant, including complimentary awareness training for their people as part of the engagement.
- Awareness for every employee on why product conformity matters
- Courses for engineers, quality staff and the compliance lead
- Internal auditor training for the quality system, as applicable, as part of the engagement
- Learner progress by department and a training status report
- New hires trained as they arrive
- A Sterling consultant reachable when a learner needs one
Keep exploring
Explore more about CE marking
Why Sterling
Want CE marking done right? Come to Sterling.
Whether you sell one product or a range across Europe, Sterling helps your team build the evidence once and keep it current, with clear ownership between design, production and compliance.
Management systems in 60+ countries since 2003
Programmes delivered for organisations across sectors and every region we serve, with one engagement team accountable across every country you operate in.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one proposal, with any third-party fees identified separately. No surprises, ever.
A system your people can use
Less documentation and maximum effectiveness: documents, training and software connected to day-to-day work, so your people adopt the system rather than tolerate it.
Expert and experienced consultants
Consultants who have advised on quality and product compliance systems across sectors and countries, and who build it properly the first time, so the assessment confirms what already works.
The Sterling Promise
What our CE marking support guarantee means
We stay with you until your agreed CE marking readiness outcome is achieved, supporting documentation, preparation and the resolution of findings. Clear explanations, practical delivery, included software and employee learning turn the investment into lasting capability.
The engagement identifies the products, legislation, outcome and responsibilities. Your organisation supplies accurate information, tests and design data. The manufacturer declares conformity, affixes the marking and remains responsible; any notified body makes its own decision. Our commitment concerns the agreed support, not the outcome of any market surveillance check.
FAQs
Frequently asked questions about CE marking
Who affixes the CE marking?
The manufacturer, once the conformity assessment is complete and the declaration is signed. Sterling never affixes the marking and never acts as a notified body.
Does every product need a notified body for CE marking?
No. Whether a notified body must take part depends on the product legislation and the conformity assessment procedure it sets. Many products are assessed by the manufacturer; others require notified body involvement.
Is CE marking a certificate?
No. It is the manufacturer's declaration that the product meets the applicable EU requirements, supported by technical documentation. Certificates issued by notified bodies form part of that evidence where required.
Talk to a consultant
Plan your CE marking with confidence.
Tell us about your products, target markets and launch date. We will help you define the scope, timeline and next steps.
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