With the axe falling on a growing number of essential legacy products, Tom Melvin explains why a plan around derogations for devices falling through the regulatory crack is now critical.
Legacy devices that did not make the 26 May 2024 deadline by which manufacturers should apply to a notified body had to be removed from the market regardless of how safe they have proved and how essential they are.
And there could be a fresh wave of casualties from 26 September, following the Medical Device Regulation amending regulation...
Market access concerns dominated at the annual BioWales In London event, where AstraZeneca set out industry’s priorities and the UK Office for Life Sciences struck an optimistic tone about how the UK will lastingly improve uptake of innovation.
European venture capital firm Sofinnova Partners’ portfolio companies BioCorteX, Bioptimus, Cure51 and Latent Labs will benefit from the investor’s new partnership with tech giant NVIDIA.
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
