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Home / ISO Certifications / CE Marking
Last updated: 2 October 2026
Many products sold in the European Economic Area must carry the CE mark. Expertvuw’s team identifies the EU laws that apply to your product, prepares the technical file and Declaration of Conformity, and coordinates testing labs and Notified Bodies where needed.
The CE mark shows that a product meets the requirements of the EU harmonisation legislation that applies to it, such as rules for machinery, low-voltage electrical equipment, electromagnetic compatibility, radio equipment, toys, personal protective equipment and medical devices. It is required to place these products on the market in the European Economic Area.
The manufacturer is responsible for CE marking. Depending on the product and its risk, conformity can be self-assessed by the manufacturer with testing and a technical file, or must involve a Notified Body designated by an EU member state. The manufacturer then signs an EU Declaration of Conformity and affixes the CE mark.
Manufacturers outside the EU often need an EU-based authorised representative or responsible economic operator, depending on the product rules. EU rules are changing — for example, the new Machinery Regulation applies from January 2027.
Basis: EU New Legislative Framework (Regulation (EC) 765/2008 and Decision 768/2008/EC); product-specific EU directives and regulations; EU Regulation 2019/1020 on market surveillance. Last updated: 27 September 2026.
The manufacturer is responsible for CE marking and the declaration.
Lower-risk products may be self-assessed; higher-risk products need a Notified Body.
A technical file must be kept, usually for 10 years after the product is placed on the market.
Non-EU manufacturers often need an EU-based responsible operator.
Using harmonised standards gives a presumption of conformity.
Some EU product laws are being replaced, such as the new Machinery Regulation from January 2027.
CE problems often come to light at EU customs or marketplaces.
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CE marking connects with these services.
Importer-Exporter Code.
Quality management system.
BIS certification for India.
Medical device licensing in India.
Identify applicable EU laws and standards.
Compare product and documents with requirements.
Coordinate testing at accredited labs.
Engage a Notified Body where required.
Compile the technical file.
Prepare the EU Declaration of Conformity.
CE compliance continues while the product is sold.
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The manufacturer. Importers and distributors have checking duties.
No. Many products can be self-assessed; higher-risk products need a Notified Body.
CE marking is based on the manufacturer’s Declaration of Conformity. A Notified Body certificate is issued only where its involvement is required.
Often yes. Many EU product laws require an EU-based responsible economic operator.
Great Britain has its own UKCA marking, while continuing to accept CE marking for many products. Rules should be checked per product.
ACS – Director, Expertvuw Management Pvt Ltd
CE compliance work is coordinated by Expertvuw’s team. Testing is done by accredited laboratories, and where EU law requires it, conformity assessment is carried out by an independent EU Notified Body.