What is the latest?
Citing the COVID-19 pandemic and a ‘grave shortage of notified body capacity’, the EU Commission has proposed delaying implementation dates for many IVD devices on the European market. The proposal delays the compliance dates for Class B, C and D devices but the IVDR date of application itself has not been pushed out, and remains 26 May 2022
The full statement and associated links can be found here.
What is the impact?
If the transitional provisions are accepted by Parliament and the European Council, IVD manufacturers can expect the below new timeframes, under which the devices may continue to be placed onto the market or be put into service:
- Class A non-sterile (‘self-certified’) – no change, must comply with the IVDR on its date of application
- Class A sterile – compliance date of 26 May 2027
- Class B – compliance date of 26 May 2027
- Class C – compliance date of 26 May 2026
- Class D – compliance date of 26 May 2025
Note that the above transition period is applicable only for devices that already have CE marking under the IVDD (Directive 98/79/EC). If an in vitro diagnostic device is newly introduced to the European market on or after 26 May 2022, it must comply with the IVDR irrespective of its classification. Meaning, if you have a mid-or-high risk IVD in development and want to be eligible for the transition timeframes, then you must have it CE marked to the IVDD before the IVDR date of application. This includes compilation of the technical file, signing the Declaration of Conformity before 26 May 2022 and registration of the IVD with the applicable European Competent Authority.
Similar to the MDR’s last minute transitional provision for Class I self-certified devices, some aspects of the IVDR have been proposed to apply for these IVDD CE marked ‘legacy’ devices. These include post-market surveillance, market surveillance, vigilance and registration of economic operators and of devices.
Also similar to the MDR transitional provisions for Class I self-certified devices, no significant changes to the design or intended purpose are allowed to the IVDD device. The device may require IVDR CE marking in order to market the device with that change.
While we believe this proposal is welcomed by all stakeholders, it must still go through the EU Parliament and the European Council and then be formally published in the EU’s Official Journal.