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Regulatory Affairs Newsletter Archive

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MedTech Europe RAC

This week, BIVDA was represented at MedTech Europe Regulatory Affairs Committee (RAC) by Stuart and Tehelj. The meeting was also attended by members of the European Commission. It was a constructive meeting with a focus on the published paper on the Future of Europe's Medical Technology Regulation, and the continued challenges on the transition to the EU IVD Regulation.
Stuart Angell
November 24, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 13 Nov)

Please note this is an extract of the original bulletin. MHRA authorises world-first gene therapy that aims to cure sickle-cell disease and transfusion-dependent β-thalassemia Page summary: Casgevy (exagamglogene autotemcel) is based on the innovative gene-editing tool CRISPR, which won its inventors the Nobel Prize in 2020 Change made: First published.  
admin
November 24, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 13 Nov)

Please note this is an extract of the original bulletin. UK Innovation Strategy: leading the future by creating it Page summary: This strategy sets our ambitions for an innovation-led economy. Change made: Linked ‘National digital twin programme (NDTP)’ to its collection page. 2,500 new places on artificial intelligence and data science conversion courses now open to applicants Page summary: Government…
admin
November 24, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 13 Nov)

Please note this is an extract of the original bulletin. Reference documents for Customs (Additional Duty) (Russia and Belarus) Regulations 2022 Page summary: Find out about the additional duties which apply on certain goods originating from Russia and Belarus. Change made: Update of the Russian and Belarusian additional duties documents to version 1.4. Additional duties on goods originating in Russia…
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November 24, 2023
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BSI webinar on EU IVDR regulatory updates

BSI are hosting a webinar about the latest IVDR regulatory updates on 28 November. The webinar will include a short recap on where the IVDR is, along with latest MDCG guidance and developments in Brussels; description of the challenges for Class D IVD’s and the status on EU Reference Labs and envision the potential ramifications for manufacturers of these updates.…
admin
November 24, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 06 Nov)

Please note this is an extract of the original bulletin. Access Consortium Page summary: The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic. Change made: Added details of the Access Consortium’s Advanced Therapy Medicinal Products Working Group. Medical devices given exceptional use authorisations during the COVID-19…
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November 17, 2023
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