CE Certification – CE Mark Certification for Medical Devices

In order to commercialize medical and in vitro diagnostic devices in the European Union, manufacturers must obtain CE Mark certification as part of their device registration efforts.

CE Marking certification verifies to EU regulators that your device meets all requirements of the Medical Devices Directive (MDD), In Vitro Diagnostic Device Directive (IVDD) or Active Implantable Medical Device Directive (AIMD) as they apply to your product. You must obtain CE Mark certification prior to marketing, distribution and sale of your product in any EU member state.

You are solely responsible as the medical device manufacturer for maintaining compliance with EU directives and securing CE Mark certification for your product, regardless of whether you outsource any or all components of your manufacturing operation.

Qualifying for CE certification and marketing your medical device in the EU requires the following steps:

1. Prepare a CE Marking Technical File or a Design Dossier for a Class III device that includes data proving compliance with the MDD, IVDD or AIMD.
2. Obtain your CE Mark certificate from a Notified Body.
3. Select and appoint a European Authorized Representative to act on your behalf within the EU.
4. Register your medical device with the appropriate Competent Authority, if necessary.

Completion of these requirements allows you to claim CE Mark certification for your device.

Emergo Group has a well-established presence in the EU, with offices in the UK, Germany, France and the Netherlands. We have assisted hundreds of medical device manufactures with their CE Marking certification efforts. Services we provide to help you obtain CE certification include product classification; technical file and design dossier preparation; ISO 13485 quality system implementation and auditing; and ISO 14871 risk assessment and management.

Please contact us for more information on the CE Mark certification process.