IVD devices (In Vitro Diagnostics) are a subset of medical devices primarily used for to testing human fluids such as blood, tissue or urine in a test tube. This may include reagents, instruments and specimen receptacles. In Europe, the In-Vitro Diagnostic Devices Directive (98/79/EC) is used to regulate IVDs. For more information download the chart below.
The IVD CE Marking approval process in Europe
The chart shown illustrates the EU IVD approval process 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 the classification of your IVD in accordance with the European In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC). The four classes include: General IVD, Self Test IVD*, List B IVD or List A IVD.
For all except General IVDs, implement a VII of the IVDD. Most companies apply the ISO 13485 standard to achieve QMS compliance.
Prepare a Technical File that provides detailed information demonstrating compliance with the In Vitro Diagnostic Devices Directive 98/79/EC.
Appoint an Authorized Representative (EC REP) located in Europe and qualified to handle regulatory issues. Place EC REP name and address on Instructions for Use and packaging wherever sold in Europe..
For all except General IVDs, your QMS and Technical File must be audited by a European Notified Body. A CE Marking certificate for your device will be issued upon successful completion of the Notified Body audit.
Your IVD(s) must be registered with the European Competent Authority (Ministry of Health) where your Authorized Representative is based. Additional notifications to other countries may be required.
Prepare a Declaration of Conformity, a legally binding document prepared by the manufacturer stating that your IVD is in compliance with the applicable Directive. You may now affix CE Marking to your IVD in Europe.
For List A IVDs, conduct ongoing batch testing and forward results to your Notified Body.
* Self-test IVDs exclude devices that are included in Annex II, List A and List B.
© 2013 Emergo Group
Chart updated: 30/05/2013