UKNI

The MHRA have published a statement of policy intent for recognition of approvals of medical devices from international regulators by the UK. This statement of policy intent is intended to inform partners of the MHRA’s direction of travel.  The legislation will come into being at the same time as the future core regulations – anticipated to be late in 2024…

The Department of Health and Social Care have laid a new draft statutory instrument before the House of Commons and the House of Lords on 14 November. Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023 (SI 2023) makes provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/746 of the European Parliament. BIVDA have provided…