Improving the availability of in vitro diagnostics: European measures

date: 10/07/2024

New measures published in the European Union’s Official Journal come into effect to improve the availability of in vitro diagnostics, for patients and healthcare providers. 

The publication of the Regulation (EU) 2024/1860 amends Regulations (EU) 2017/745 on medical devices (MDs) and (EU) 2017/746 on in vitro diagnostics (IVDs). The main changes include granting more time to companies to transition to the new European Union (EU) rules on IVDs, introducing a new obligation on manufacturers to inform national authorities, the economic operators concerned and the health sector in case of disruption or discontinuation of supply of certain medical devices and 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.

More time to IVD companies to implement the In Vitro Diagnostic Medical Device Regulation
The new measures give more time for manufacturers to transition to the new In Vitro Diagnostic Medical Device Regulation (IVDR) without compromising safety while reducing the risk of shortages.

The additional time granted to companies depends on the type of device:

  • all IVDs with a IVDD certificate (list A, list B and self-test devices) will have a transition period until December 2027;
  • Class D devices, with a high individual risk and a high public health risk, such as HIV or hepatitis tests, will have a transition period until December 2027;
  • Class C devices, with a high individual risk and/or a moderate public health risk,  such as cancer tests, will have a transition period until December 2028;
  • Class B devices, with a moderate individual risk and/or a low public health risk, such as pregnancy tests, and sterile devices class A, with a low individual risk and a low public health risk, such as blood collection tubes, have a transition period until December 2029.

The regulation specifies the conditions set to benefit from this additional time. 

New obligation on manufacturers
Manufacturers are also required to give prior notice if they anticipate an interruption or discontinuation in the supply of certain IVDs or MDs. They must provide this information at least 6 months in advance to competent authorities, as well as distributors and healthcare providers. This will allow them enough time to take action to guarantee patient care.

Eudamed
The measures will also facilitate the launch of parts of the European database on MDs, 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 MDs available on the European market.
You can read the official press release on the Commission website.

Last updated on 10/07/2024