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UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes draft policy statement on International recognition of medical devices

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…
admin
May 22, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Draft statutory instrument published in respect of Northern Ireland

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…
admin
December 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Draft statutory instrument for the Windsor Framework published

The draft statutory instrument on the Windsor Framework has been published. This will now go through a vote in the House of Commons, but is likely to be implemented into UK law. Secondary legislation will then be developed in order to action the contents of the Framework. BIVDA have requested confirmation from MHRA and DHSC on how this Framework will…
admin
March 24, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC webinar on the Windsor Framework

DHSC have provided the following update for stakeholders: DHSC would like to invite you to a webinar at 2pm on Thursday 16 March, on the recent announcement from the Government on the significant changes to medicines in the Windsor Framework. We will be joined by colleagues from MHRA, and will be discussing: The replacement of the EMA by the MHRA…
admin
March 9, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC notice on the Windsor Framework

DHSC have provided the following update for stakeholders: You will have seen the announcement yesterday on the Windsor Framework, which concludes an agreement between the UK and the EU on the Northern Ireland Protocol. This framework includes simplifications to customs and Sanitary and Phytosanitary (SPS) processes that will significantly reduce requirements on traders. We are working through the details of…
admin
March 9, 2023
HighlightsHighlights Archive

Northern Ireland Protocol Bill passes first reading stage despite strong criticism

On Monday, Prime Minister Boris Johnson secured a 74-vote majority on the Northern Ireland Protocol Bill to shred post-Brexit trade rules relating to the area. Despite winning the vote, there were a number of senior Conservatives speaking out against the legislation, although none voted against it. Leading criticism of the Bill was former PM Theresa May who warned of reputational…
Ben Kemp
July 1, 2022
Membership NewsMembership News Archive

Northern Ireland Protocol Update

The UK Government has this week introduced a bill which takes unilateral action to alter the Northern Ireland Protocol, which they claim will fix four key issues. These issues are: burdensome customs processes, inflexible regulation, tax and spend discrepancies and democratic governance issues. They believe these changes are fundamental to restoring stability in Northern Ireland and protect the integrity of…
Natalie Creaney
June 17, 2022
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