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

MHRA weekly update (WC 10 July)

Please note this is an extract of the original bulletin.   Borderline products: how to tell if your product is a medical device and which risk class applies Page summary: How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device. Change made: An additional section…
admin
July 21, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA guidance update: Regulation of In Vitro Diagnostic medical devices in Great Britain

The MHRA have recently updated their Guidance on the regulation of In Vitro Diagnostic medical devices in Great Britain to: Reflect the current requirement for UKCA marking (section 3.15) Add UK approved bodies and UKCA mark/marking in the Conformity assessment procedure flow charts (section 3.11) instead of using CE mark/marking and NBs The rest of this document remains the same.…
admin
July 21, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 10 July)

Please note this is an extract of the original bulletin. Notice to exporters 2023/12: The Export Control (Amendment) Regulations 2023 Page summary: The Export Control Joint Unit (ECJU) has amended the Export Control Order 2008 (“the 2008 Order”) and the retained Council Regulation (EC) No 428/2009. Change made: First published. Notices to exporters Page summary: Notices to exporters published by…
admin
July 21, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 10 July)

Please note this is an extract of the original bulletin. England Rare Diseases Action Plan 2023 Page summary: The second action plan setting out how the Department of Health and Social Care and delivery partners will implement the UK Rare Diseases Framework in England. Change made: Updated to link to the now published report on the Breaking Down Barriers focus…
admin
July 21, 2023
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

BIVDA and MHRA bilateral meeting held on 18 July

On 18 July, BIVDA and MHRA met for our latest one-on-one meeting. The aim of these meetings is to ensure our relationship remains strong and we are able to collaborate on projects key to the IVD sector. The discussions are in addition to our usual day-to-day work with MHRA, specifically involving MHRA’s senior and executive staff. MHRA recently published their…
Ben Kemp
July 21, 2023
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