In a move that is sure to be welcomed by the diagnostics industry, on 23 January 2024, the European Commission announced proposals (Commission proposal and press release) to extend the transitional periods for certain in-vitro-diagnostic medical devices (“IVDs”) under Regulation (EU) 2017/746 (“IVDR”). This follows similar action taken by the Commission in early 2023 to extend the transitional provisions under Regulation (EU) 2017/745 (the “MDR”) (see our prior blog post here). The rationale applied for the latest proposal is the same as before – it aims to “ensure availability of safe devices, essential for healthcare systems, and protect patient care”. Specifically, the latest IVD proposals are intended to address ongoing concerns regarding the availability and readiness of notified bodies to perform IVDR conformity assessments and the high number of IVDs that have yet to transition to the IVDR. The new proposals (once adopted) will provide manufacturers with more time to comply with the new requirements of the IVDR. Relatedly, manufacturers will be required to give notice if they foresee interruption of supply of their devices.
In addition, to improve the transparency and coordination, the Commission has proposed to accelerate the roll out of the European database on medical devices (“EUDAMED”) so that certain modules are mandatory as from late 2025. Continue Reading European Commission Proposes to Extend Transitional Periods for In-Vitro-Diagnostic Medical Devices