Regulation (EU) No 2022/112 of the EUROPEAN COMMISSION of 25 January 2022 amends Regulation (EU) 2017/746 on the deferred application of transitional provisions for certain in vitro diagnostic medical devices and conditions for in-house devices.
https://eur-lex.europa.eu/eli/reg/2022/112/oj/eng
The EU Commission press release confirmed that the EU Parliament and the Council of the EU have adopted the text.
On October 14, 2021, the European Commission proposed to amend the transitional period for devices covered by the In Vitro Diagnostic Regulation (IVDR) 2017/746. This urgent proposal to amend the implementing regulations of the IVDR is in response to exceptional circumstances associated with significant differences between the Regulation and the IVD Directive. In addition, the transition to the IVDR has been significantly affected by the COVID-19 pandemic and its impact on the volume of IVD devices available after the Date of Application (DoA) of May 26, 2022.
The proposal will need to be approved by member states and published in the Official Journal of the European Union (OJEU) before it can enter into force. At the moment, we cannot inform you when the approved publication will take place. Once the DoA for the IVDR enters into force, it will remain unchanged from May 26, 2022, but the IVDR will have new transition periods for devices placed on the market after that date, subject to conditions.
IVDR Proposed transition timelines
Although the proposal delays the transition timelines for IVD devices, the DoA will not change. The transition timelines are subject to the Declaration of Conformity under the IVDD being signed prior to the DoA and there being no material change to the device thereafter. If a device undergoes a significant change as defined by the IVDR, all requirements of the IVDR apply, including conformity assessment by a notified body as required according to the new classification of the device.
The transitional timelines mean that for new IVD Devices (i.e. devices without a signed DoC) the IVDR will be fully applicable from May 26, 2022.
There is still a mountain to climb to ensure all products are certified to IVDR in time, so we recommend you focus on completing your Technical Documentation.
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