In order to commercialize medical and IVD devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory 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. For a more detailed look at the European regulatory process, see or download the chart below.
The European CE medical device approval process explained
The chart shown illustrates the CE approval process in Europe and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page.
Determine which EU Medical Device Directive applies to your device: 93/42/EEC – Medical Devices Directive (MDD) or 90/385/EEC - Active Implantable Medical Devices Directive (AIMDD):
Determine classification of your device using Annex IX of the Medical Devices Directive (MDD): Class I (non-sterile, non-measuring), Class I (sterile, measuring), Class IIa, Class IIb or Class III/AIMD. Active implantable medical devices are subject to the same regulatory requirements as Class III devices..
For all devices except Class I (non-sterile, non-measuring), implement Quality Management System (QMS) in accordance with Annex II or V of the MDD.
Most companies apply the ISO 13485 standard to achieve QMS compliance.
For Class III/AIMD devices, prepare a Technical File that provides detailed information on your medical device demonstrating compliance with MDD 93/42/EEC.
Appoint an Authorized Representative (EC Rep) located in Europe. They should be qualified to handle regulatory issues. Place EC REP name and address on Instructions for Use and, packaging.
For all devices except Class I (non-sterile, non-measuring), your QMS and Technical File or Design Dossier must be audited by a Notified Body, a third party accredited by European authorities to audit medical device companies and products.
For all devices except Class I (non-sterile, non-measuring), you will be issued a European CE Marking Certificate for your device and an ISO 13485 certificate for your facility following successful completion of your Notified Body audit. CE Marking certificates are typically valid for 3 years. ISO 13485 certification must be renewed every year.
All Class I devices must be registered with the Competent Authority where your EC REP is based. Most EU member states do not require registration of Class IIa, IIb or III devices.
Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable Directive. You may now affix the CE Marking.
* Class III / AIMD devices will likely required clinical study data. Existing clinical data may be acceptable. Clinical trials in Europe must be pre-approved by a European Competent Authority.
© 2013 Emergo Group
Chart updated: 30/05/2013