Last updated: 23 February 2024
See updated at the end of the post.
On 23 January 2024, the European Commission published a proposal to extend transition periods for certain in vitro diagnostic medical devices (IVDs), gradual roll-out of Eudamed and an information obligation in case of interruption of supply.
Why is there a need for a new proposal?
The in vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746) (EU IVDR ) has been applicable in EU Member States and Northern Ireland since 26 May 2022.
- However, the available data shows that today, a considerable number of in vitro diagnostics currently on the market do not yet comply with the new rules nor have been replaced by new devices.
- The situation is especially critical for high-risk IVDs, which are devices used, for example, to test for infections in blood and organ donations.
- To improve the availability of such essential devices, today’s proposal gives more time for manufacturers to apply the new rules, under certain conditions, without compromising safety requirements. This is very important, also taking into account the fact that many manufacturers producing IVDs are small and medium size enterprises.
This proposal for targeted amendments addresses two urgent issues:
Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions.
Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices.
In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs.
You can view the proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices, here.
What the new regulation proposes
Under the current provisions, these rules would apply from 26 May 2025 for high risk IVDs or 26 May 2027 for lower risk IVDs. The additional time granted to companies depends on the type of device:
- high individual and public health risk devices such as HIV or hepatitis tests (class D) would have a transition period until December 2027;
- high individual and/or moderate public health risk devices such as cancer tests (class C), would 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), have a transition period until December 2029.
The proposal also requires manufacturers to give prior notice if they foresee the interruption of supply of IVDs or medical devices, so that Member States have more time to take action to ensure patient care.
Why is the Commission proposing to introduce a mechanism of prior notice by manufacturers in case of disruption of supply of certain medical devices and IVDs?
To ensure availability of devices, Member State authorities and healthcare providers need to know in advance whether devices will be discontinued, and whether such discontinuation may pose a risk to patients or public health.
The Commission is therefore proposing that manufacturers provide this information to competent authorities, as well as distributors and healthcare providers. They have to provide this information six months in advance, so that national authorities and healthcare providers have enough time to consider mitigating measures to ensure patient safety and a high level of public health.
Is there a fact sheet available?
Yes, a fact sheet entitled Health Union : Helping the transition to the new rules on medical devices and in vitro diagnostics is available and you can view it here.
Is there a Q & A available?
Yes, a Q & A on in vitro diagnostics and the European Database on Medical Devices (EUDAMED) is available and you can view it here.
Progress so far
On 14 February 2024, the Permanent Representatives’ Committee agreed on the text of the Commission proposal without amendments as a mandate for the Presidency to enter into negotiations with the European Parliament.
On 21 February 2024, the European Council endorsed key updates to the law on medical devices that will help prevent shortages and ease the transition to greater transparency and access to information.
The regulation approved by EU member-state representatives on 21 Feb 2024 amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by:
- further extending the transition period for certain IVDs (particularly those that are high-risk)
- enabling a gradual roll-out of EUDAMED, the new electronic database
- requiring manufacturers to flag up potential shortages of critical medical devices and IVDs
The next step is that the compromise agreement will be formally adopted by the European Parliament and the Council following legal-linguistic revision.
You can view the final text agreed with the European parliament on amending the Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR) here.
You can read the full press release here.
Further information:
- Implementation deadlines for the EU In Vitro Diagnostic Medical Device Regulation further postponed – Alex Denoon et al, Bristows LLP 29 January 2024.
Source: European Commission, European Council
Updates
| Date | Update |
|---|---|
| 23 Feb 2024 | New section Progress so far added. |
| 7 Feb 2024 | Added new section entitled Further information. |