BIVDA responded to the MHRA’s focused consultation on the proposed Pre-Market amendment to the UK Medical Device Regulation. The consultation, which closed on 5th January, focused on: International Reliance and associated pathways Proposal to remove the requirement for a physical UKCA mark Proposed route for UK Conformity Assessment Renewal of four pieces of assimilated EU law into UK Law which…
Ben KempJanuary 7, 2025