In Vitro Diagnostic Regulation (IVDR)

What is the In Vitro Diagnostic Regulation (IVDR)?

The In Vitro Diagnostic Regulation (IVDR) is the current European Union (EU) regulatory legislation for placing in-vitro diagnostic devices on the EU market, making them available and putting them into service.

The IVDR regulation was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replacing the EU’s former Directive on in vitro diagnostic medical devices (98/79/EC).

As a European regulation, it is effective in all EU member states and EFTA states immediately without needing to be transposed into the law of respective states. However, national laws may be adapted to back up some requirements in more detail.

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Key IVD amendments

Four additional regulations have been enacted with the primary purpose of providing adequate time and resources to ensure continued availability of devices on the EU market.

IVDR Transition Timeline

Only “legacy” devices meeting the following conditions can benefit from the IVDR transition timelines:

a) those devices continue to comply with Directive 98/79/EC;
b) there are no significant changes in the design and intended purpose;
c) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;

The transition period depends on the classification of the device and whether it was CE-marked under the IVDD by self-declaration or by certification with a Notified Body. The following timelines apply: