CE Marking for Medical Devices

In order for your products to be placed on the European market, they must meet the requirements of the relevant product directives or regulations. Intertek will help you understand and meet these requirements to ensure your product completes the CE Marking process efficiently and successfully.

Before the CE Mark may be affixed to a medical device and legally sold within the European Union, the manufacturer or exporter must complete the following:

• Prepare Technical Documentation (Technical File) to show the product's compliance with applicable essential requirements and conformity assessment procedures of the applicable device directive
• Register their device with the appropriate Competent Authorities
• Receive a device-specific CE Certificate from a Notified Body

8-Step Process

Navigating the CE marking process does not have to be painstaking. In fact, Intertek makes it as easy as the following steps:

1. Classify your product - Class I, IIa, IIb, and III according to the classification rules in Annex IX of the MDD:
   • Class I. Devices with low risk such as external patient support products.
   • Class IIa/b. Devices with medium risk such as electro-medical devices.
   • Class III. Devices with high risk such as cardiovascular catheters.
   *Note that: Some Class I and all Class IIa, IIb, and Class III devices require Notified Body approval.
2. Determine your certification process based on your device class
3. Fulfill the essential requirements - Ensure that your medical device fulfills the essential requirements of the Medical Device Regulation (MDR).
4. Establish a monitoring system - As a manufacturer, you are required to monitor your products once they are on the market, in case accidents involving your products occur.
5. Establish an accident reporting system - If an accident or near-accident involving any of your products takes place, you are obligated to report this to the authorities.
6. Issue a Declaration of Conformity
7. Save the documentation for five years. Declaration of conformity, technical documentation, reports, and certificates from the Notified Body etc. must be kept for at least five years after the product has been taken out of production. The MDR requires that records for implantable devices be kept for 15 years.
8. Register with the appropriate authorities in Europe

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