Last updated: 13 July 2024
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This post summarises the proposal and main events so far concerning the extension of the IVDR transition periods.
Timeline of events
| Date | Event |
|---|---|
| 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 2024 | 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 |
| 30 May 2024 | The European Council formally adopted the amending Regulation. It will enter into force following publication in the EU’s Official Journal. |
| 9 July 2024 | The new Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devicesText with EEA relevance was published in the EU’s Official Journal. This Regulation shall enter into force on the day of its publication (9 July 2024) in the Official Journal of the European Union. Article 1, point (1), and Article 2, point (1), shall apply from 10 January 2025. |
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?
| IVD Device Type | Transition 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 tubes | Will 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.
Publishing of the regulation
The new Regulation (EU) 2024/1860 was published on 9 July 2024 in the OJEU.
Is there a fact sheet explaining the changes?
Yes there is. You can view it here.
Sources:
References:
Further reading
1. State of play of MDR/IVDR implementation (Information session on MDR/IVDR for international regulators – 4 July 2024). This slide deck should help to to better understand the evolving legislation and transition periods.
2 Transition periods under the IVDR extended – Jackie Mulryne et al, 9 July 2024, Arnold & Porter, biosliceblog.com