What is CE Marking / UKCA Marking

CE Marking 

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:

  • active implantable / in vitro diagnostic medical devices
  • medical devices
  • personal protective equipment
  • and other different equipments

The CE marking is not required for items, for example:

  • chemicals
  • pharmaceuticals
  • cosmetics and foodstuffs
CE Marking

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

  1. Determine the regulations / directives and harmonized standards and other requirements that the product complies with
  2. Determine whether product classification requires third-party notified body to participate in verification
  3. Prepare Technical files required by the preliminary directive
  4. Contact European Union Authorised Representative to register the local medical equipment government department
  5. Affix the CE mark & EU Authorized Representative information on your product and make an EC Declaration of conformity.
CE Mark Logo

UKCA Marking

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

UKCA

Looking for a helpful CE / UKCA Marking Consultant?

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Frequent Asked Question

The  duration depend on product category and product complexity.

It depend on the product category and product complexity, availability of testing report, production control and ISO Certification.

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 .

In general, the company can put the CE / UKCA Mark  on the packing & product after completion of CE / UKCA registration .

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