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 supply of IVDs to the EU market, Articles 110 and 113 of the IVDR set out a number of transitional provisions (TPs).
TPs give more time to manufacturers of certain devices already placed on the market to comply with the IVDR.
When do transitional provisions apply?
On 26 May 2022, the IVDR replaced the in vitro diagnostics directive (IVDD).
TPs may apply to IVDs CE marked in line with the IVDD where there are no significant changes in the design and intended purpose.
IVDs ‘up classified’ under the IVDR can also avail of TPs once the manufacturer has drawn up a declaration of conformity before 26 May 2022.
Although some IVDs may be subject to TPs, IVDR requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices, are fully applicable from 26 May 2022.
Article 112 of the IVDR calls out exceptions to some key TPs relating to Eudamed.
Change to IVDR transitional provisions
In January 2022, the European Commission adopted Regulation 2022/112. Amongst other things, this changed the transitional timelines for devices set out under Article 110 of the IVDR.
We have provided a summary of the key information outlined in this amendment below.
Table 1: * IVDR Articles 110(3) and 110(4) as amended by Regulation (EU) 2022/112.
IVDs with an IVDD notified body certificate
These certificates will continue to be valid up until 26 May 2025 at the latest. Economic operators may continue to make available or put into service devices with a certificate issued before 26 May 2022 until 26 May 2025.
IVDs without a notified body certificate issued under the IVDD
Class A non-sterile IVDs must be IVDR compliant by 26 May 2022.
Some IVDs did not require notified body oversight under the IVDD but will require it under the IVDR. These IVDs can remain on the market after 26 May 2022 only if the manufacturer drew up the IVDD declaration of conformity before this date.
The transition times for these IVDs depend on their IVDR classification as described in table 1 above.
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.
Transitional provisions for in-house manufactured devices
Regulation 2022/112 introduces 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).