EU regulation or directive
A legal instrument that creates binding obligations within its scope.
VerifyApplicability, dates, roles and exact requirements.
EU product compliance hub
EU compliance, CE marking and European standards guides
Identify applicable EU product rules, understand how standards support conformity, plan technical evidence and find the correct catalogue or specialist route.
- Law sets the obligation
- Standards provide technical solutions
- Evidence supports the conclusion
Live standards catalogue
Search current standards records on Genorma
Check current references, editions, amendments, formats, availability and commercial information before selecting a document.
Choose your starting point
What are you trying to achieve?
The correct route depends on the product, intended purpose, economic operator role, target countries and applicable legislation. Start with the closest objective, then verify the details against the governing legal act.
01Product compliance
I am placing a product on the EU market
Check whether CE marking applies and plan the manufacturer, importer or distributor responsibilities.
Open CE marking guide → 02Standards selectionI need to identify the right standards
Understand EN, EN ISO, EN IEC and harmonised-standard status before choosing a document.
Start with harmonised standards → 03Testing and assessmentI need testing or third-party support
Match the activity to the exact method, accredited scope and independence requirement.
Find laboratory support → 04Medical devices and IVDsI work under the MDR or IVDR
Explore classification, quality systems, technical documentation, evidence and notified-body preparation.
Find MDR and IVDR support →Core guide library
Four essential guides for the European compliance system
These guides explain the relationship between EU law, European standardisation, technical evidence and conformity assessment.
CE
CE Marking
Determine whether CE marking applies, identify every relevant EU legal act, choose the assessment route and prepare the required evidence.
EU lawTechnical fileEU DoC
Read guide →hENHarmonised Standards
Understand OJEU references, presumption of conformity, restrictions, transition periods and why not every EN is harmonised.
OJEUCitationPresumption
Read guide →CENCEN European Standards
Learn how CEN develops voluntary European standards, how EN documents are adopted nationally and how EN ISO references are formed.
ENEN ISONational adoption
Read guide →CLCCENELEC Standards
Explore European electrotechnical standardisation, EN IEC adoption, European modifications and electrical-compliance applications.
EN IECElectricalCENELEC
Read guide →Complete guide library
Browse compliance and standards guidance
Search the library or filter by subject. Every guide link remains present in the original page HTML and can be followed without JavaScript.
13 guides shown
Core product-compliance guide
Copyright and access
CE Marking Guide
Identify applicable EU legislation, conformity-assessment routes, technical documentation and marking responsibilities.
CE markingTechnical fileEU DoC
Open guide →
Legal relationship of standardsHarmonised Standards
Verify OJEU citations, covered requirements, restrictions, dates and the edition that may support presumption of conformity.
hENOJEUPresumption
Open guide →
European standardisationCEN European Standards
Understand EN, EN ISO, national adoption and the role of CEN across non-electrotechnical sectors.
ENEN ISOCEN
Open guide →
Electrotechnical standardisationCENELEC Standards
Compare IEC and EN IEC documents, European modifications and electrical-standardisation routes.
EN IECElectricalCENELEC
Open guide →
Sector discoveryEuropean Standards by Industry
Browse 27 sector guides for machinery, medical devices, construction, digital technologies, energy, transport and more.
27 sectorsIndustry guidesDiscovery
Open guide →
High-demand standards familiesTop European Standards
Review important standards families used across quality, construction, machinery, toys, medical equipment and environmental management.
Popular familiesSelection guidesEN
Open guide →
Access Standards Legally
Check licensed copies, document formats, copyright restrictions, edition status and authorised access routes before use.
LicensingCopyrightCatalogue
Open guide →
Organisational licensingShare Standards Across a Company
Distinguish single-user documents, multi-user licences, subscriptions, intranet rights and controlled-document workflows.
Multi-userIntranetDocument control
Open guide →
Testing supportAccredited Laboratories
Find support matching the exact test method, product, measurement range, edition and required accredited scope.
ISO/IEC 17025TestingScope
Open guide →
Management-system supportISO Auditors and Consultants
Find support for implementation, gap analysis, internal audit and certification preparation while keeping roles distinct.
ISO 9001Internal auditImplementation
Open guide →
Medical-device supportMDR and IVDR Consultants
Explore support for classification, technical documentation, quality systems, clinical evidence and notified-body preparation.
MDRIVDRISO 13485
Open guide →
ICT and telecommunicationsDigital, Telecom and Electronics Standards
Explore radio, cybersecurity, software, data and communications standards with their European regulatory context.
ETSIRadioCybersecurity
Open guide →
Machinery and risk reductionMachinery Standards
Start with the machine, intended use, lifecycle hazards, applicable legislation and the standards supporting risk reduction.
MachineryRiskEN ISO 12100
Open guide →
No guides match this search. Try a broader term or choose All guides.
A controlled decision process
An eight-step EU product compliance process
The steps may overlap, but each creates a decision or record that should be controlled before the product is placed on the market.
- 01
Define the product and intended purpose
Document the finished product, users, foreseeable use, variants, environment and the economic operator placing it on the market.
Expected output: Product definition and scope statement - 02
Identify applicable EU legislation
Check every legal act that may apply instead of assuming one directive or regulation covers the complete product.
Expected output: Legal applicability register - 03
Map essential or mandatory requirements
Translate the legal requirements into design, safety, performance, information and evidence obligations.
Expected output: Requirements matrix - 04
Select standards and technical methods
Review candidate standards by scope, edition, exclusions, harmonised status and relationship to the product and hazards.
Expected output: Standards and methods register - 05
Determine the assessment route
Confirm whether self-assessment is permitted or whether a notified body, laboratory or another independent activity is required.
Expected output: Conformity-assessment plan - 06
Generate and review evidence
Complete risk assessment, calculations, testing, inspections, quality controls and the records needed to support the claims.
Expected output: Verified technical evidence - 07
Compile documentation and declarations
Prepare the technical documentation, instructions, labels and declaration with the correct products, legislation and references.
Expected output: Controlled compliance file - 08
Maintain post-market conformity
Monitor complaints, changes, incidents, supplier evidence, standards updates and corrective actions throughout the product lifecycle.
Expected output: Lifecycle review process
Key distinctions
Understand the difference between law, standards and assessment
These terms are connected, but they describe different legal, technical and organisational functions. Treating them as interchangeable creates avoidable risk.
European Standard
A technical document adopted by a recognised European standards organisation.
VerifyScope, edition, amendments and national adoption.
Harmonised standard
An EN prepared under a standardisation request and cited for specific EU legislation.
VerifyOJEU reference, restrictions, dates and requirements covered.
ISO or IEC standard
An international technical document that may or may not be adopted as an EN.
VerifyWhether an EN ISO or EN IEC adoption exists and whether legal citation applies.
Conformity assessment
Activities used to demonstrate that specified requirements are fulfilled.
VerifyPermitted procedure, evidence and independence requirements.
Accredited laboratory
A laboratory assessed for competence within a defined accredited scope.
VerifyExact method, product, range, edition and current scope.
Notified body
An organisation designated to perform specified third-party tasks under named EU legislation.
VerifyLegislation, conformity-assessment procedure and notification scope.
CE marking
The manufacturer declaration that applicable EU harmonisation requirements have been addressed.
VerifyWhether the product is covered and the complete legal process is finished.
Before citing or purchasing a standard
Five checks before the reference enters your compliance file
Legal scope
Confirm the product, intended use, operator role, market and legislation before selecting a standard.
Exact document
Check the full reference, title, part number, edition, amendments and corrigenda.
Publication status
Verify whether the document is current, superseded, withdrawn or subject to a transition period.
Official citation
For harmonised standards, verify the applicable official citation, dates, restrictions and requirements covered.
Use rights
Confirm licence, user, location, sharing and document-control rights before distributing a standard.
Specialist support
Find support by task and verified scope
Define the activity before choosing the provider. A consultant, laboratory, certification body and notified body perform different functions.
Primary verification routes
Use official and authorised sources for final checks
Guides help organise the research. Final conclusions should be checked against the applicable legislation, official citations, designation databases and licensed standards records.
EUEUR-LexEU legislation and official documentshENHarmonised standardsEuropean Commission sector pages and citationsNBNANDONotified bodies and notification scopesYEYour EuropeProduct requirements and market responsibilitiesSGSafety GateProduct safety alerts and recallsENCEN and CENELECEuropean standardisation information
Frequently asked questions
Questions that should be answered before the project advances
The answers below provide a reliable starting point. They do not replace product-specific legal and technical analysis.
View all compliance FAQs →Are European standards legally mandatory?
Standards are generally voluntary technical tools. Binding obligations arise from legislation, contracts or other legal instruments. When a harmonised standard is correctly used, it may support presumption of conformity only for the requirements and conditions covered by the citation.
Does CE marking apply to every product?
No. CE marking is required only for products covered by EU legislation that expressly requires it. It must not be applied to products outside that framework.
Is every EN a harmonised standard?
No. An EN becomes relevant as a harmonised standard only when the exact reference is cited for the applicable EU legislation and the citation conditions are met.
Can an ISO or IEC standard replace an EN?
Technical content may be related or identical, but the document reference, European adoption and EU legal status must be checked separately. An ISO or IEC publication is not automatically an EN or a harmonised standard.
Where can I obtain the official text of a standard?
Use an authorised national standards body or another authorised standards distributor. European-Standards.com supports discovery and navigation but does not reproduce protected full standards text.
How do I know whether a laboratory is suitable?
Compare the exact test method, product or material, measurement range, edition and report purpose with the laboratory current accredited scope. Accreditation of the organisation does not mean every offered activity is accredited.
When is a notified body required?
The applicable legislation and conformity-assessment procedure determine whether a notified body is required. The organisation must also be notified for the relevant legislation and task.
How often should compliance references be reviewed?
Review them when the product, intended use, supplier, process or legislation changes and on a scheduled basis appropriate to the risk. Standards, citations and transition dates can change independently.
Choose the next action
Move from general guidance to a verified project route
Search the live catalogue, browse standards by industry or describe the product and decision so we can direct you to the most relevant support pathway.