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The “Conformité Européenne” (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the European legislation, specifically with European directives and European regulations.
Unlike other certification marks, CE marking is not granted by a particular regulatory body, although certain products require an independent conformity assessment by a notified body to ensure they meet CE certification requirements. Ultimately, manufacturers are responsible for the proper use of CE marking on their products.
A CE Mark is a symbol that must be affixed to many products before they can be sold on the European market. The mark indicates that a product:
- Fulfills the requirements of relevant European directives and regulations
- Meets all the requirements of the relevant recognised European harmonised performance and safety standards
- Is fit for its purpose and will not endanger lives or property
The presence of CE marking further indicates that appropriate technical documentation supporting the use of the mark is available and can be provided by the manufacturer, importer, or person responsible for placing the product on the EU market upon request.
Devices that are intended to be used for medical purposes are required to be CE marked under formerly the Medical Device Directive MDD, the Active Implantable Medical Device Directive AIMDD and the In-vitro Device Directive IVDD. These directives have been replaced by the Medical Device Regulation (MDR) (Regulation (EU) 2017/745) and by the In-vitro Diagnostic Regulation (IVDR) (Regulation (EU) 2017/746). MDR and IVDR introduce a life-cycle approach to ongoing CE marking compliance.
It is therefore important to obtain and/or maintain CE marking compliance for medical devices.
When working on the development of new medical devices, the Quality Management System (QMS) is a key element that should be put in place together with the maintenance of Technical Files throughout the lifecycle of a device.
- When developing new medical devices, liaising with Notified Bodies, preparing Technical File documentation and a product life cycle planare important activities. A Quality Management System should be in place, as well aspost-market surveillance.
- For devices that have CE mark registration, it will be necessary to perform device vigilance and ongoing review of the QMS and Technical File.
- For a registered medical device from another manufacturer, a full transfer process required for the CE mark will be needed.