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European IVD Regulatory Approval Process

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.

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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 CE approval process for In Vitro Diagnostics (IVDs) 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.

Step 1
Determine classification of your device using the In Vitro Diagnostic Directive (98/79/EC): General IVD (Self-certified), Self-Testing IVD*, List B IVD (Annex II), List A IVD (Annex II)

Step 2
For the General IVD (Self-certified) class, implement QMS in accordance with Annex III. The QMS does not require certification from a Registrar.

For all other IVD classes, implement Quality Management System (QMS) in accordance with Annex IV or VII of 98/79/EC.**

Most companies apply the ISO 13485 standard to achieve QMS compliance.

Step 3
For all classes, prepare a Technical File (Design Dossier for List A IVD), which provides detailed information about your IVD and demonstrates compliance with the Essential Requirements of Annex I of the IVDD 98/79/EC.

Step 4
Appoint an Authorized Representative (EC Rep) located in Europe who is qualified to handle regulatory issues. Place EC REP name and address on Instructions for Use, outer packaging, or device label.

Step 5
For General IVD (Self-certified), no Notified Body audit. Manufacturers of Self-Certified devices will self-affix the CE Marking to their devices.

For all other classes, your QMS** and Technical File must be audited by a European Notified Body, a third party accredited by the European authorities to audit medical device companies and products. Your CE Marking certificate for your device and ISO 13485 certificate for your facility will be issued upon successful completion of the Notified Body audit. ISO 13485 certification must be renewed every year. CE Marking certificates are typically valid for 3 years.

Step 6
For all classes, 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.

Step 7
Your IVD(s) must be registered with the European Competent Authority (Ministry of Health) where your Authorized Representative is based. Some EU member states require additional registration of devices placed on their markets.

Step 8
For the General IVD (Self-certified) class, you must remain in compliance with 98/79/EC, though yearly audits are not required.

For all other classes, you will be audited by a Notified Body each year to verify ongoing compliance with 98/79/EC, depending on the chosen conformity assessment Annex. Failure to pass the audit will invalidate your CE Marking certificate.

Step 9
For List A IVD (Annex II), conduct ongoing batch testing and forward results to your Notified Body.

* Self-testing IVDs exclude devices that are included in Annex II, List A and List B.

** Self-test IVDs have the option to follow Annex III, like General IVDs. This route to conformity assessment would only require the device to have a NB-issued CE marking certificate for the devices.

This is a simplified overview of the process. Your Notified Body may choose to audit your submission and request more documents, which will add time to your approval.

Chart updated: 21/07/2019