IVDR transitional provisions

This webpage provides information for industry stakeholders about the In Vitro Diagnostic Medical Devices Regulation (IVDR) transitional provisions.

What are transitional provisions?

To support the continued supply of IVDs to the EU market, Articles 110 and 113 of the IVDR set out a number of transitional provisions.

These provisions give more time to manufacturers of certain devices already placed on the market to comply with the IVDR.

The IVDR replaced the In Vitro Diagnostics Directive (IVDD) on 26 May 2022.

While certain transitional provisions apply to devices CE-marked under the IVDD, IVDR requirements for post-market surveillance, market surveillance, vigilance, registration of economic operators and devices, are fully applicable.

Extension to IVDR transitional provisions

On 9 July 2024, Regulation (EU) 2024/1860 entered into force. Amongst other things, it extends the IVDR’s transitional provisions as follows:

Table 1: IVDR Articles 110(3) and 110(4) as amended by Regulation (EU) 2024/1860.

Regulation (EU) 2023/607 also removed the ‘sell off provision’ for both the MDR and IVDR. This means that IVDs already placed on the market can continue to be made available or put into service until the revised expiry of the certificate or until the shelf life of the device.

For example, devices which are already held within health institutions before May 2022 can continue to be used in those hospitals until the end of their shelf life or expiry date.

The commission has developed a Q&A document. This gives practical information on the application of Regulation 2024/1860. We recommend you read this Q&A to understand how this amendment may affect your organisation.

Does the extension apply to all Directive-compliant devices?

The extension only applies to devices which meet the criteria outlined in Regulation (EU) 2024/1860 as follows:

When do I need to place a UDI carrier on my IVD?

Article 24(4) notes that manufacturers must place UDI carriers on the label of IVDs and on all higher levels of packaging.

Article 113 of the IVDR sets out a number of provisions and covers the staggered application of device labelling and UDI carriers. We have provided a summary of UDI timelines in the table below.

These provisions and UDI timelines apply to IVDR compliant devices. As per the Commission's Q&A, IVDR UDI requirements don't apply to legacy devices.

Transitional provisions for in-house manufactured devices

Regulation 2022/112 as amended by Regulation (EU) 2024/1860 introduced a phased application of the requirements for IVDs made and used within health institutions.

We provide a summary of these timelines in the table below. You should read these timelines together with Article 5(5) of the IVDR.

Transitional provisions for class D IVDs

The Medical Devices Coordination (MDCG) has developed guidance on the application of transitional provisions for certification of class D IVDs under the IVDR. This document provides information for IVD manufacturers on how to apply IVDR provisions related to expert panels and European Union reference laboratories (EURLs).