European Commission proposal for IVDR transition timelines
IVDR revised transition provisions
REGULATION (EU) 2022/112 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices.
The proposal has now been ratified by both the European Parliament and the European Council and will shortly appear in the Official Journal of the European Union (OJEU).
The EU Commission press release confirming that the EU Parliament and the EU Council have adopted the text.
On 14 October 2021, The European Commission proposed to amend the transition period of devices covered by the In Vitro Diagnostic Regulation (IVDR) 2017/746. This urgently drafted proposal to change the implementation arrangements of the IVDR is in response to the exceptional circumstances associated with the significant differences between the Regulation and the IVD Directive. In addition, the move to the IVDR has been substantially impacted by the COVID-19 pandemic and the impact it has had on the volume of IVD devices available after the Date of Application (DoA), 26 May 2022.
The proposal will need to be approved by the member states and published in the Official Journal of the European Union (OJEU) before entering into force. At this moment, we cannot inform you of when the approved publication will occur. Once in force, the DoA for the IVDR will remain unchanged from 26 May 2022, however the IVDR will have new transition periods for devices placed on the market after this date, subject to conditions.
The below table outlines BSI’s interpretation of the proposal, but we advise you to read the published document carefully and understand the implications for your business.
Proposed transition timelines IVDR
Although the proposal delays the transition timelines for IVD devices, the DoA will not change. The transition timelines are dependent on the Declaration of Conformity under the IVDD being signed prior to the DoA and that there are subsequently no significant changes to the device. If a device undergoes a significant change, as defined by the IVDR, then the complete requirements of the IVDR apply, including conformity assessment by a notified body as required according to the new classification of the device.
The Transition timelines mean that for new IVD Devices (i.e. devices that do not have a signed DoC), the IVDR will apply wholly from 26 May 2022.
There is still a mountain to climb to ensure all products are certified to the IVDR in a timely fashion, so we recommend you maintain your current focus on completing your Technical Documentation.
We want to thank you all for your efforts over the last few years and the patience you have shown through unprecedented times.