The New IVDR Timeline: The European Commission’s 2024 Proposal

The European Commission has recently proposed an extension to the transition periods for certain In Vitro Diagnostic (IVD) devices. This proposal, published in January 2024, is a significant development in the field of medical devices and patient safety since it provides more time both to manufacturers and the notified bodies to get the IVD devices to comply with the new regulations. The amendment of the IVDR has been adopted by the European Parliament and the Council on the 13th of June 2024. This is now published in the Official Journal of the European Union, as Regulation (EU) 2024/1860.

Background

To better ensure patient safety and public health protection, the EU approved new regulations for medical devices and in vitro diagnostics in 2017. The industry has been granted more time to implement these regulations and has made significant progress, but the progress was not fast, due to several reasons such as limited number of Notified Bodies.

The key elements of the new IVDR amendment

The key elements of the proposal are as follows:

1. Extended Transition Periods:The transition period to the new rules for legacy IVD devices (i.e. the devices that have been already on the market) covered by a certificate or a declaration of conformity issued before May 26, 2022, is extended from May 26, 2024, to December 31, 2027, 2028, and 2029 depending on the risk class (see the timeline depending on risk-class, below).
2. Gradual Roll-Out of EUDAMED: Speeding up the launch of some parts of the European Database on Medical Devices – EUDAMED, in order to improve transparency.
3. Information Obligation in Case of Interruption of Supply: Manufacturers are obliged to notify the Member States in case of disruption of supply of certain medical devices or in vitro diagnostics.

The transition timeframes for legacy IVDs are as follows:

• Legacy IVDs Class D (IVDR) must be compliant by December 2027.
• Legacy IVDs Class C (IVDR) must be compliant by December 2028.
• Legacy IVDs Class B and Class A sterile (IVDR) must be compliant by December 2029.