The introduction of the IVDR came with very substantial regulatory changes to the regulatory framework for IVD’s. One of the most significant changes is the increased involvement of independent notified bodies for the conformity assessment that is proportionate to the classification of the device. Under the IVDD, only a small number of high-risk devices equating to around 8% of IVD’s on the market required the involvement of a notified body. Under the IVDR, around 80% of IVD’s on the market with require the involvement of a notified body.
There is also an issue that persists that concerns the limited capacity of notified bodies for IVDR. Currently, there are only 12 notified bodies that are designated for IVDR, with a further 8 applications that are in progress. This is quite a low number when compared to the 43 Notified Bodies that are designated under the MDR.
The combination of low notified body numbers designated under the IVDR with the fact that many manufacturers are not yet prepared for the requirements of the IVDR will hence result in delays in the certification of IVD’s under the IVDR. Subsequently, this will result in shortages of vital IVD’s on the EU market.
With concerns that there will be IVD shortages, the EU commission is proposing an extension of the transition periods for IVDR. This will help to mitigate the risk of shortages of IVDs by giving manufacturers and notified bodies more time, under certain conditions, to complete the necessary conformity assessment procedures, without lowering the requirements.
Under the current legislation, depending on the class, IVD manufacturers have until May 2025, May 2026 and May 2027 to comply with the IVDR requirements. Under the new proposed legislation, manufacturers would be given an extra 2 years and a half to fully comply with the IVDR requirements when compared to the current legislation. The table below highlights the current deadlines and the newly proposed deadlines for the different classes of IVD devices.
| Under Current Legislation | New Proposed Legislation |
| May 26, 2025, for Class D devices | December 2027 for Class D devices |
| May 26, 2026, for Class C devices | December 2028 Class C devices |
| May 26, 2027, for Class B devices | December 2029 Class B devices |
| May 26, 2027, for Class A sterile devices | December 2029 Class A sterile devices |
Useful Links
The Q&A can be accessed using the following link
The proposal can be accessed using the following link
The factsheet can be accessed using the following link
The press release can be accessed using the following link
