What is CE Marking?

CE mark is abbreviated as Conformitè Europëenne which is a French term. Ce mark is defined as the European Union`s mandatory conformity marking for regulating the goods sold in European Union`s countries since 1985. CE marking declares a manufacturer`s declaration that the product complies with the EU`s New Approach Directives. These directives not only apply to the products in the EU but also to the product that is manufactured in or designed to be sold in the European Economic Area (EEA). The CE mark signifies that the product sold in European Economic Area (EEA) have been evaluated to ensure that they fulfill the stringent safety, health, and environmental standards.

CE marking is a part of the EU`s harmonized legislation which is managed by Directorate–General.

CE mark is a symbol that must be affixed to all the products under New Approach Directives before selling them to the European market which indicates that a product –

• Fulfills the requirements of relevant European Product Directives.
• Meets all the requirements of the relevant recognized European harmonized performance and safety standards.
• Is fit for its purpose and will not endanger lives and property.

The image of the CE mark is shown below which is a must for all the products before selling them in European Union.

• The process to obtain CE Marking -

As the product`s manufacturer, it is the sole responsibility of the manufacturer to declare conformity with all the requirements. The License is not required to affix a CE mark on the product. However, before doing so, the following is a must -

• Ensure conformity with all relevant EU - wide requirements.
• Determine whether the product can be assessed by the manufacturer itself or must involve a notified body.
• Assemble technical documentation demonstrating conformity: get more pieces of information about technical documents.
• Draft and sign an EU declaration of conformity.

Once the product bears the CE Marking – if the competent national authority requests, the manufacturer must provide them with all the information and supporting documentation concerning the CE Marking.

If the product has been tested and verified by a notified body, then the identification number of a notified body must be included with the CE Marking and if the product is not verified by an independent body, then the manufacturer must ensure that the CE marking complies with the technical requirements.

The CE mark must be visible, readable, and permanent.

• CE Marking for Medical Device

To sell a medical device in European Union (EU), the manufacturer must obtain a CE Marking of their product. CE Marking indicates that the medical equipment conforms with all applicable EU standards and allows the manufacturer to sell the products in all EU countries. Although CE is not a quality mark, the manufacturer must achieve the performance, quality, safety, and efficiency standards of your product type to comply with the EU Medical Device Regulation (MDR 2017/415).

If the medical device is a Class I (provided sterile and has a measuring attribution), Class IIa, Class IIb, or Class III, then it falls under Annex II, List A; Annex II, List B, or is self-testing, then the manufacturer will receive the CE certificate from a notified body as per the fees they have mentioned for a particular class of medical device.

Class I medical device which is non-sterile and has a non-measuring function does not require any CE certificate.

CE Marking must be visible, readable, and permanent and it must be applied to the product`s instruction for use to indicate that it complies with the criteria of the law.

Ce marking must be affixed with the packaging of the product itself. In case, if the device is sterile then CE Marking must be affixed to the packaging that keeps the product sterile. In the case of a device involving a Notified body, then CE Marking must be accompanied by the identification number of a notified body.

The model for CE marking is mentioned in Annex V of the Medical Device Regulation.

Author – Shireen Khan

Technical Coordinator & Client Service

(UKMHRA-EU MDR/IVDR- US FDA)

www.i3cglobal.com

Sophiya Williams is one of the best regulatory consultants providing services for 10+ years.