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Extended Validity of IVDD Certificates
Another change introduced by Regulation 1860/2024/EU concerns the validity of certificates issued under the old IVDD. Certificates that were still valid at the date of July 9th 2024, are now valid until December 31, 2027. Certificates that expired before July 9, 2024 will also be extended, if manufacturers meet specific conditions, including:
- Keeping compliance with IVDD under surveillance,
- No significant device changes or risks considered unacceptable,
- Implementing a Quality Management System (QMS) compliant with IVDR by May 26, 2025,
- Signing an agreement with a notified body for IVDR certification by May 26, 2025 (or by September 26, 2025, for some steps).
In addition, originally IVDR included a "sell-off" period, in other hands, meaning that after one year from the original transition deadline, IVDs sold under IVDD could no longer be sold. However, Regulation 1860/2024/EU removed this restriction to avoid lacking of diagnostic devices on the European market.
Legacy Devices and IVDR Requirements
The new transitional provisions cover devices considered "legacy devices" i.e. all those devices placed on the market still in accordance with the IVDD (98/79/EC), after the implementation date of Regulation 746/2017/EU (IVDR) and with a valid certificate or declaration of conformity issued in accordance with the same directive.
These devices are still allowed on the market, but they must follow some IVDR prescriptions, such as:
- Vigilance, including reporting serious incidents and implementing corrective actions,
- Following Post-Market Surveillance (PMS) requirements, including PMS plans, Post-Market Performance Follow-Up (PMPF), and Periodic Safety Update Reports (PSUR) for higher-class devices,
- Registering economic operators and devices (now the registration is mandatory in the national databases and voluntary in EUDAMED. However, the EUDAMED registration is highly recommended).
Notified bodies that issued IVDD certificates must continue to provide the appropriate surveillance of these devices, unless the manufacturer chooses a different notified body for the future IVDR certification, in which case the new notified body could bring the surveillance of the legacy devices if required.
The Pressure on Manufacturers and Notified Bodies
One of the big problems with the new IVD regulation is the limited number of notified bodies available to handle IVDR certifications. With IVDD, only about 20% of devices required certification. With IVDR, this number has increased to about 80 percent of devices requiring certification. To date, only 13 notified bodies are able to issue IVDR certifications. This increase in requirements compared to the small number of notified bodies that can certify devices under IVDR has created a bottleneck, slowing down the process for many manufacturers.
During the transition period, a great deal of effort is required of manufacturers to meet IVDR requirements, particularly with regard to scientific validity and post-marketing surveillance.
Postmarket surveillance has become more challenging, with new requirements based on the new risk classes of IVDR devices, such as implementation first in a PMS plan and then in a PMS report or periodic safety update report (PSUR) for higher risk devices.
The development of performance and clinical trials is more rigorous in IVDR. Many manufacturers who, under IVDD, have not demonstrated strong performance evidence must now demonstrate that they have robust, diligently conducted studies with sound scientific underpinnings.
Many manufacturers will now have to collaborate with clinical research organizations (CROs) to conduct these studies.
IVD world for women's health
There are many in vitro diagnostic devices related to women's health; pregnancy tests, Kit for HPV Screening test, software for genetic mutation analysis of major female cancers (breast and uterus) - these are just a few of the many in vitro diagnostic devices dedicated to women's health. Below are some examples of IVDs that fall under the IVDR regulation that will need to meet the new regulatory requirements (deadlines).
|
IVD |
Self-testing / Near patient test / Professional use |
Class of risk according to IVDR |
Deadlines according to IVDR (available on the market) |
|
Pregnancy tests |
Self- testing |
B |
May 27, 2025 or at expiring date of the Certificate |
|
Kit for HPV Screening test |
Professional use |
C |
Dec 31, 2028 |
|
Software for genetic mutation analysis of major female cancers |
Professional use |
C |
Dec 31, 2028 |
Many examples could be added. PQE can also support IVD manufacturers dedicated to women's health through FemTech. FemTech supports manufacturers of IVDs dedicated to women's health to ensure clinical device compliance.
Conclusion
The transition from IVDD to IVDR poses great challenges for manufacturers. They must now meet for example more stringent clinical and post-market requirements. Although the revised deadlines in Regulation 1860/2024/EU provide more time to comply with Regulation 746/2017/EU, manufacturers still face several challenges in ensuring that their devices meet IVDR standards. Acting quickly and ensuring sound science and robust documentation is critical to successfully address this transition.
