CE Marking for Medical Devices

Gain market access with a CE mark

CE marking medical devicesCE Marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. The Directives outline the safety and performance requirements for medical devices in the European Union (EU). The CE mark is a legal requirement to place a device on the market in the EU.

BSI has two Notified Bodies, one in the UK (0086) and one in the Netherlands (2797), both of which have full scope designations to the IVDR and MDR.

Key resources to help you gain CE certification

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