European Parliament votes to extend IVDR transition period

Last updated: 31 May 2024

See updates at the end of the post.

On Thursday 25th April, the European Parliament voted overwhelmingly in favor of a proposal by the European Commission to extend the transition period of the In Vitro Diagnostic Medical Devices Regulation (IVDR) and hasten the application of EUDAMED requirements.1
 
Members of parliament voted 511-1 with 21 abstentions in favor of the Commission’s proposal, giving test makers additional time to transition to the new Regulation (EU) 2017/746.1

On 30 May, the European Council formally adopted the amending Regulation. It will enter into force following publication in the EU’s Official Journal.

What are the key measures of the proposal?

The key measures in the proposal include: 

  • granting more time to companies to transition to the new EU rules on IVDs,
  • introducing a new obligation on manufacturers to inform national authorities and the health sector in case of disruption of supply of certain medical devices. They must provide this information 6 months in advance to competent authorities, as well as to distributors and healthcare providers
  • allowing for the gradual roll-out of the European Database on Medical Devices – Eudamed.

The measures give more time to consider possible actions to safeguard patient care in instances where certain devices are discontinued and increase transparency regarding medical devices on the market.

What are the new transition periods for companies to transition to the new rules on IVDs?

Device TypeTransition period
high individual and public health risk devices such as HIV or hepatitis tests (class D) Will have a transition period until December 2027.
high individual and/or moderate public health risk devices such as cancer tests (class C)Will have a transition period until December 2028.
lower risk devices (class B) such as pregnancy tests and (class A) sterile devices such as blood collection tubesWill have a transition period until December 2029
What does the adoption of this proposal mean for the EUDAMED database?

It will facilitate the launch of parts of the European database on medical devices, Eudamed. From the beginning of 2026, the use of several parts of Eudamed will become mandatory. This will increase transparency in the EU and provide an overview of medical devices available on the European market.

Adoption of the proposal

With the Parliament’s adoption of the proposal (proposed by the Commission in January 2024), the European Council formally adopted the amending Regulation on 30 May 2024. It will enter into force following publication in the EU’s Official Journal.

The Commission will work together with Member States and all stakeholders to provide the necessary support to implement this legislative amendment. This will include clarifying in which cases manufacturers must notify a disruption of supply.

Is there a fact sheet explaining the changes?

Yes there is. You can view it here.

Timeline of events
DateEvent
23 Jan 2024 European Commission published a proposal to update the provisions of the IVDR and MDR with the aim of mitigating shortages of critical medical devices
21 Feb 2024.The European Council endorsed the compromise agreement reached with the European Parliament
25 Apr 2024The European Parliament voted overwhelmingly in favor of a proposal by the European Commission to extend the transition period of the In Vitro Diagnostic Medical Devices Regulation (IVDR) and hasten the application of EUDAMED requirements.
30 May 2024The European Council formally adopted the amending Regulation. It will enter into force following publication in the EU’s Official Journal.
Sources:

European Commission

References:
  1. RAPS
  2. RAPS
Update(s)
DateUpdate(s)
31 May 20241) Section heading What are the next steps? changed to Adoption of the proposal . Section text updated to confirm approval of the proposal by the European council on 30 May 2024. Links added/updated.

2) New section Timeline of events added.

3) References updated