Regulation (EU) 2022/112 of 25 January 2022 was published in European Official Journal L 19/6 of 28 January 2022. The Regulation amends Regulation (EU) 2017/745 as regards transitional provisions for certain IVD devices and deferred application of the conditions for in-house devices.
Amendment of the regulation provides IVD manufacturers more time to switch to the IVDR regulation and allows the currently tests on the market to remain available to patients, laboratories, hospitals, and healthcare professionals.
The date of full application of the regulation remains on 26 May 2022 and applies to those CE-marked IVD devices that do not require the participation of a notified body (non-sterile Class A devices) and to “new” IVD devices (that are not certified, or declarations of conformity issued in accordance with Directive 98/79/CE).
Transitional periods have changed in relation to other risk classes:
- for devices with the highest risk (class D) are subject to the requirements from 26 May 2025,
- for class C devices, the date of introduction is 26 May 2026 and
- for class B devices and class, A, devices placed on the market in a sterile state are subject to requirements from 26 May 2027.
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