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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

MHRA publishes a new MedTech roadmap

The MHRA have published a roadmap towards the future regulatory framework for medical devices. This sets out the relevant timelines into 2025. The roadmap intends to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances. According to the timelines, MHRA intends to run stakeholder discussions on the future core regulations during the…
admin
January 9, 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
Membership NewsMembership News Archive

BIVDA publishes a position paper on Domestic Assurance

This week, BIVDA have published a position paper on domestic assurance routes to place IVD products on the Great Britain market. This paper presents the stance of the IVD industry in relation to domestic assurance and preferred routes to enter the British market. It highlights the considerations and recommendations to create well-structed market routes, with input provided by the BIVDA…
Ben Kemp
August 25, 2023
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

New Statutory Instrument to extend market access for Medical Devices in Great Britain

The UK Parliament have published Statutory Instruments 2023 No. 627 “The Medical Devices (Amendment) (Great Britain) Regulations 2023” to amend the UK Medical Devices Regulations (MDR) 2002 (S.I. 2002/618). The purpose of the amendment is “to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain.” This SI will…
admin
June 23, 2023
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UKCA statutory instrument published on implementation timelines

  The UK Government have published an amendment to the UK Medical Device Regulations 2002. Notably, this is the first statutory instrument shaping the new UKCA requirements in Great Britain. BIVDA have provided our initial understanding of this text below. Please consult your own legal teams before acting on any of this advice, as it is our own interpretation. We…
admin
May 5, 2023
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UL free webinar on UKCA for IVD medical devices

UL have made available a 30 minute webinar on the upcoming UK Medical Device Regulation changes. This is a free webinar available from the UL website. It covers current timelines, expected requirements based on the MHRA consultation response, and transitional arrangements.
admin
April 3, 2023
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Latest UKCA extensions do not apply to medical devices

This includes: The General Product Safety Regulations 2005 Supply of Machinery (Safety) Regulations 2008 Electromagnetic Compatibility Regulations 2016 Pressure Equipment Safety Regulations 2016 Electrical Equipment (Safety) Regulations 2016 Simple Pressure Vessels (Safety) Regulations 2016 Radio Equipment Regulations 2017 These timelines have been extended for 12 months to allow extra time for compliance. Importantly, these timeline changes do not impact medical…
Natalie Creaney
November 18, 2022
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Department for Business, Energy & Industrial Strategy (BEIS) Announcement on UKCA Marking (Non-Medical Devices) – Further Webinar Dates Announced

Following on from the BEIS announcement to introduce legislation to continue recognition of the CE marking and reversed epsilon marking until 31 December 2024, a further two webinars will be held on Monday 21 November 2022 for anyone unable to attend the previous webinar session on Wednesday 16 November. Please find the registration links below to register for either of…
Natalie Creaney
November 18, 2022
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