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01Entering This Market
Entry to the EU market does not rest on a single document, but on compliance with the full set of legislation applicable to the product. The CE mark is the visible face of this compliance; it is not itself a document but the manufacturer's declaration. A product may fall under several pieces of legislation at once, and each must be satisfied separately.
02Background to the Regime
The EU's conformity system was established with the "new approach" adopted in 1985 and its basic logic has not changed since. The legislation does not write how a product is to be made but which ESSENTIAL REQUIREMENTS it must meet; the technical expression of those requirements is prepared by specially mandated standardisation bodies (CEN, CENELEC, ETSI). The legislation can thus remain in force without having to be updated alongside technology.
The second defining choice is that control is placed not BEFORE placing on the market but after. In most product groups no authority examines the product before it is placed on the market; the manufacturer makes its own declaration and puts it on sale. Control is exercised by the market surveillance authorities of member states, by taking samples from products on the market. In the EU, therefore, what matters is not "obtaining a certificate" but "keeping the technical file defensible".
A notified body comes into play only where it is accepted that the risk cannot be left to the manufacturer's own declaration. This is not a quality preference but the consequence of risk classification: there is no body for low voltage and electromagnetic compatibility, there is one without exception for lifts and gas appliances, and for medical devices it varies with the risk class of the product.
The legal value of a harmonised standard is often misunderstood. Complying with the standard is NOT mandatory; where it is complied with, a PRESUMPTION of conformity with the legislation arises, that is, the burden of proof is reversed. A manufacturer that does not follow the standard can still place a product on the market, but must show through its own technical file that it meets the essential requirements, and that route is far harder in practice.
In recent years the system has widened: horizontal legislation (chemical restrictions, waste and recycling, energy efficiency, ecodesign) creates obligations independently of the CE marking, and new instruments such as the digital product passport are arriving. Even where a product's CE file is complete, placing it on the market remains unlawful unless these horizontal obligations are met.
03Acceptance of Foreign Test Reports and Documents
- As a rule the EU ACCEPTS tests carried out in third countries: the legislation asks not where the test was done but whether it was done to the harmonised standard. This makes the EU one of the most flexible regimes in the world.
- Under legislation resting on manufacturer declaration (LVD, EMC, RoHS) it is not even legally mandatory for the laboratory to be accredited; but a report without accreditation is markedly weaker to defend in market surveillance.
- Under legislation where a notified body is involved, the body makes its own assessment; it may accept existing foreign reports as input, but the decision to accept belongs to the body and it will have any test it finds lacking repeated.
- A CB Scheme report (IECEE) markedly reduces test repetition in electrical product safety; the national differences section is met separately.
- For medical devices, third-country certificates are not directly valid: the MDR/IVDR require their own conformity assessment and an authorised representative established in the EU is mandatory.
04Defining Features of the Regime
- CE is not a quality certificate but a declaration of regulatory compliance; the manufacturer affixes the mark
- A notified body is not involved in every piece of legislation: absent for LVD, EMC and RoHS; always present, without exception, for lifts, gas appliances and measuring instruments
- Compliance with harmonised standards is not mandatory, but it provides a presumption of conformity
- The technical file is retained for the period specified by legislation from the product's placement on the market (10 years under most directives)
- Affixing the CE mark to a product outside the scope is prohibited
- Horizontal legislation such as REACH and RoHS creates obligations independently of CE
05Local Representative and Responsible Party
Manufacturers established outside the EU are expected, under many pieces of legislation, to appoint an authorised representative established in the EU; this is mandatory for medical devices (MDR/IVDR). Market surveillance legislation also requires an EU-established responsible person for certain product groups — this may be the manufacturer, importer, authorised representative or fulfilment service provider, and their contact details must appear on the product or its packaging.
07Entry Process
- 01Determining the Applicable DirectivesIt is determined which EU directives apply based on the product's description, intended use and technical characteristics. An electrical product may fall under LVD, EMC and RoHS simultaneously; if it has a radio module, RED replaces these.
- 02Selecting the Conformity Assessment ModuleEach directive determines the module to be followed based on the product's risk class. In some modules the manufacturer makes its own declaration; in others, a notified body becomes involved.
- 03Testing Against Harmonised StandardsConformity with harmonised standards published in the EU Official Journal is demonstrated through testing; this provides a presumption of conformity with the legislation.
- 04Risk Assessment and Technical FileRisk analysis, design calculations, test reports, the instruction manual and label samples are compiled in the technical file.
- 05Authorised Representative and Responsible PersonAn authorised representative is appointed for non-EU manufacturers; for relevant product groups, an EU-established responsible person is designated and their contact details are marked on the product.
- 06EU Declaration of Conformity and MarkingThe declaration is signed and the CE mark is affixed in the manner prescribed by the legislation; if a notified body is involved, its identification number is added.
08Customs and Labelling
- The instruction manual and safety information must be in the official language of the member state where the product is sold
- The CE mark is affixed visibly, legibly and indelibly; its proportions are preserved
- The manufacturer's name, registered trade name and address appear on the product or its packaging
- The importer is also obliged to add its own name and address
- The product must be identifiable by a batch or serial number
- The EU Declaration of Conformity is supplied with the product or made accessible
09Common Mistakes
- Incomplete identification of the legislation applicable to the product — the most common and most costly mistake
- Not testing the final product because an approved radio module is used; the module's certificate does not demonstrate the final product's conformity
- Using an outdated version of the harmonised standard instead of the current one
- The technical file not being accessible within the EU
- The instruction manual not being available in the target country's language
- Affixing the CE mark to a product outside the scope
10Calendar
The certification timeline varies with the product, the required test workload, sample shipping time and the authority's workload; for this reason, no duration in days or weeks is given on these pages. The main factors determining the timeline are: whether testing must be performed in the target country, whether a factory audit is required, the time to appoint a local representative, and the current maturity of the technical file. A realistic timeline for your product is provided in writing at the quote stage.
Market access regimes change frequently: scope lists are updated, transition periods are extended, new requirements are added. These pages describe the structure of the regime and who bears the obligation; the applicable scope and dates for your product are confirmed from the current legislative text at the quote stage.
11Frequently Asked Questions
Is there such a thing as a 'CE certificate'?
Legally, no. What exists is the EU Declaration of Conformity, signed by the manufacturer. Where a notified body is involved, the body issues its own certificate (e.g. an EU Type-Examination Certificate); this is the basis for the declaration, not the declaration itself.
Is CE mandatory in Turkey?
Yes. Turkey has transposed EU technical legislation into its national legislation, and the CE mark is also mandatory in Turkey for products within scope.
Is CE also sufficient for the United Kingdom?
Great Britain is a separate regime (UKCA). The United Kingdom has made arrangements to continue accepting the CE mark for many product groups, but this does not apply to all groups; the current status for your product group must be confirmed separately.
European Union roadmap for
Tell us about your product; we'll share the required steps, documents and timeline in writing.