The document summarizes the regulatory process for in vitro diagnostic devices (IVDs) in Europe under the In Vitro Diagnostic Directive (98/79/EC). It outlines the classification of IVDs, requirements for quality management systems and technical files, roles of notified bodies and authorized representatives, and timelines and costs associated with the approval process depending on the IVD classification. The process can take from 3-5 months for self-certified IVDs to 9-12 months for list A IVDs and involves implementing quality systems, obtaining notified body audits, and registering with authorities.

1. Europe
© 2017 Emergo – Have comments or suggestions about the content of this table? Email us at marketing@emergogroup.com. Table updated 02/2017. EmergoGroup.com/europe
Determine classification of your IVD 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)
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The Regulatory Process for In Vitro Devices (IVD)
Self-testing IVDs exclude devices that are included in Annex II, List A and List B.
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.
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.
A QMS is not formally required.
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 will
be issued upon successful completion of the Notified Body audit.
No Notified Body audit.
Manufacturers of Self-Certified
devices will self-affix the CE
Marking to their devices.
You will be audited by a Notified Body each year to ensure ongoing compliance with 98/79/EC.
Failure to pass the audit will invalidate your CE Marking certificate.
The self-certified CE Marking
certificate does not expire
as long as you remain in
compliance with 98/79/EC.
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.
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.
If you do not have a location in Europe, appoint an Authorized Representative (EC REP) in Europe who is qualified to
handle regulatory issues. Place EC REP name and address on Instructions for Use, outer packaging, or device label.
EC REP
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.
*
IVD
Conduct ongoing batch
testing and forward results to
your Notified Body.
LOT
Current Process
Directive 98/79/EC

2. Europe
Notes
1. The time frames shown above are typical for the majority of IVD submissions but assume that your device does not contain animal tissue, medicinal
substances or employ entirely novel technology. Your length of approval will depend on the quality and completeness of your technical documentation
and how much time you take to address additional information requests from authorities after submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME
THAN WHAT IS SHOWN ABOVE.
2. Registrations remain valid for the time specified as long as you do not make changes to your IVD, intended use or indications for use.
3. We recommend starting the re-registration process no later than the time period specified above. However, please consult with your distributor or
regulatory expert well before this suggested time to avoid any lapse in your registration.
4. Our rating of the complexity of the registration process is based on our experience and the opinion of nearly 1,000 QA/RA professionals worldwide who
were asked to rate the difficulty of registering a device in each country. The European CE Marking process is considered the mid-point to which all other
markets are compared.
5. Prices in US Dollars for a single IVD device. 1 = Less than $5,000; 2 = $10,000 - $15,000; 3 = $15,000 - $30,000; 4 = $30,000 - $50,000; 5 = $50,000 or
more. Estimated cost includes registration application fees, in-country representation, Notified Body audit fees, submission preparation consulting and
translation of documents, if required. Costs assume you already have approval for your device in the United States, Canada, Australia, or Japan. Costs do
NOT include product testing, clinical trials or ISO 13485 implementation, if applicable. These costs are generally spread across many markets and thus not
specifically attributed to a European CE submission.
EmergoGroup.com/europe
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© 2017 Emergo – Have comments or suggestions about the content of this table? Email us at marketing@emergogroup.com. Table updated 02/2017.
Time, Cost, and Complexity of IVD Registration
Self-testing IVDs exclude devices that are included in Annex II, List A and List B.
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.
*
Device classification
in Europe
General IVD
Self-certified
Self-Testing IVD* List B IVD
(Annex II)
List A IVD
(Annex II)
How long you should
expect to wait after
submission until
approval is granted.1
Not applicable 3-5 months 3-5 months 9-12 months
Validity period for CE
Marking certificate.2 Not applicable 3 years 3 years 3 years
Registration renewal
should be started this
far in advance.3
Not applicable 2 months 2 months 2 months
Complexity of the
registration process
for this classification.4
Overall cost of gaining
regulatory approval.5
Simple Complex Simple Complex Simple Complex Simple Complex
Low High Low High Low High Low High
1
1
2 3
3
4
44
Current Process
Directive 98/79/EC