JD Supra

European Commission Proposes Amending Transitional Provisions in Medical Devices and In Vitro Diagnostics Regulations

On 6 January 2023, the European Commission adopted a proposal to amend the transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro ...
JD Supra

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance ...
RAPS

Asia-Pacific Roundup: TGA posts guidance on transition to device reclassification after consultation confusion

Australia’s Therapeutic Goods Administration (TGA) has published guidance on the transitional arrangements for the reclassification of certain medical devices. The guidance follows a consultation that ...