Amending Regulation (EU) 2024/1860 on the extension of IVDR transition periods and early EUDAMED launch has been published in the Official Journal of the EU (OJEU) on July 9, 2024. The latter marks the date of entry into force.
As a reminder, three new steps essential to advancing the implementation of Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR):
- An additional extension of the transition periods for legacy devices under the IVDR.
- Earlier obligatory implementation of most parts of the Eudamed medical device database.
- A prerequisite for manufacturers to give prior notice before disrupting the supply of certain essential medical devices and IVD medical devices (IVDs).
The new extended transition periods for legacy devices under the amending regulation are:
IVD Risk Class under IVDR | New extensions of transition periods | Former ends of transition periods as of 25 January 2022 |
---|---|---|
Class D | 31 December 2027 | 26 May 2025 |
Class C | 31 December 2028 | 26 May 2026 |
Class A and B placed on the market in a sterile condition | 31 December 2029 | 26 May 2027 |
Non-legacy devices, i.e. IVDs which do not have a notified body certification under the former IVD Directive (IVDD) or which were not up-classified due to changed IVDR classification rules, were required to meet the original to meet the original IVDR compliance deadlines of 26 May 2022.
Despite this extra time, it is vital that companies continue with their preparation. There are deadlines for launching formal application to notified bodies and signing written agreements with these testing bodies, which are created to help keep the manufacturer’s impetus going. These can be found under article 110 of the amended IVDR. Additional guidance can be found here.
Eudamed
Amending Regulation (EU) 2024/1860 also provides for a change in approach regarding Eudamed. Formerly, an obligatory use of Eudamed only applied, once the database with all its planned modules was fully functional. With the amending regulation, a gradual and compulsory implementation of Eudamed is provided for. As soon as individual modules are ruled functional, they become obligatory – without waiting for the full set of six to be ready for a single launch.
Guidance and further details will become available here shortly. A recently published presentation lays out the following deadlines:
– mandatory use of the actor, UDI, device and Certs/NBs/market surveillance modules beginning 2026 (4 modules)
– mandatory use of vigilance module first half 2026 (1 module)
The presentation can be found here.
Supply of critical devices
According to the amending regulation, medical device and IVD manufacturers are required to provide prior notice about any interruption of supply of certain critical medical devices or IVD medical devices. They must do this six months ahead and provide the warning to relevant authorities, health institutions, healthcare professionals and economic operators to whom they supply the devices. Further guidance is expected to be published shortly under this link.
Source: European Commission
Accompanying this subject we recommend the following content on our website
- Extension of IVDR transition periods and early launch of Eudamed takes last hurdle
- Manufacturers must act now to satisfy IVDR
- MDR extended transition timelines and removal of MDR and IVDR sell-off period adopted
- Registering a legacy device in Eudamed is a good step
- Different options for IVD medical devices until Eudamed becomes fully operational