CE Marking
The Conformitè Europëenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold and is manufacturers’ declaration that the product meets EU standards for health, safety, and environmental protection within the European Economic Area (EEA).
The mark consists of the CE logo and, if applicable, the four digit identification number of the Notified Body involved in the conformity assessment procedure.
Not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked.
CE marking applies to products, ranging from electrical equipment to toys and from civil explosives to medical devices. The full list of these product categories is below:
The CE marking is not required for items, for example:
According to Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR) , the EU manufacturer can apply directly to the local government agency (Competent Authority).
If the medical device is manufactured outside of EU, the EU Authorized Representative assists the manufacturer to apply.
Application for CE Mark registration process
The UK Government have introduced new UKCA conformity marking to replace CE Marking, and this will effective on 1st Jan 2021
The new UKCA Marking requirement will be used for products being placed on the market in Great Britain (England, Wales and Scotland), replacing the EU requirements for CE Marking.
It covers most products that previously required the CE mark.
UKCA marking will replace CE marking for any products that are or will be placed in the UK market.
• Mandatory for NEW applicable products placed on the UK market from 1st Jan 2021.
• Mandatory for ALL applicable products placed on the UK market from 1st Jan 2022.
• The recognition of existing CE marking will be valid in the UK until 1st Jan 2022.
Note: Conformity Assessment tasks must be carried out by a UK Approved Body.
Northern Ireland will conform to the same requirements but under a UKNI marking.
For more details, you may browse the post UKCA Marking.
No hidden cost. Completion within budget and timeframe.
Our Office support
Precise CE briefings / trainings to client for quick glance
Straight forward & Simple CE documentation. Minimum workload is required.
How long does it take for CE / UKCA Mark Registration
The duration depend on product category and product complexity.
How much do we pay for CE / UKCA Mark ?
It depend on the product category and product complexity, availability of testing report, production control and ISO Certification.
What do Consultant provide service in assisting CE / UKCA Mark Registration?
Absolutely Yes. In general, ISO Consultant will help technical files and liaise with EU Representative / UK Responsible Person guide your company to prepare until getting CE Mark / UKCA Mark .
When can we use CE / UKCA Mark ?
In general, the company can put the CE / UKCA Mark on the packing & product after completion of CE / UKCA registration .
