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Regulatory Affairs Newsletter Archive

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

UK Health Security Agency weekly update (WC 28 Aug)

Please note this is an extract of the original bulletin. How to become a private provider of COVID-19 testing   Page summary: Guidance for prospective providers on how to be listed as a testing provider for general population testing. Change made: Added note on legislation and guidance being under review. Minimum standards for private sector providers of COVID-19 testing Page summary: Sets out the…
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September 8, 2023
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

UL Standards update

UL have revised their UL 4200A- Products Incorporating Button Batteries or Coin Cell Batteries. The scope has been updated to include: 1.1 These requirements cover household type products that incorporate or may use button batteries or coin cell batteries. 1.2 These requirements do not cover products that exclusively use zinc-air battery technologies. 1.2A These requirements do not cover toy products…
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September 8, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

EU MDR and EU IVDR Communication Survey

The European Commission DG Sante has launched a “MDR and IVDR Communication Survey”. The objective of this online survey is to better understand the information needs around the EU Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR). It focuses on how the stakeholders are affected by the regulations. Members are encouraged to participate in this survey.…
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September 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The UK Trader Scheme to close on 30 September

Following the Windsor Framework agreement between the Government and the EU agreed the Windsor Framework, a new scheme, the UK Internal Market Scheme (UKIMS), for the movement of ‘not at risk’ goods into Northern Ireland is established. This scheme replaces the UK Trader Scheme (UKTS) from 30 September 2023. Organisations are encouraged that they move goods into Northern Ireland to…
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September 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Customs Declaration Service: announcement of phased approach for exports

HMRC announced a staged approach to the deadline to move across to the Customs Declaration Service (CDS) for exports to allow businesses more time to prepare and ensure IT is thoroughly tested. Some businesses may still be able to start making export declarations through CDS by Thursday 30 November 2023.  All other export declarations should be made through CDS by…
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September 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Public consultation on disclosure of industry payments to the healthcare sector

The Department of Health and Social Care (DHSC) has launched a public consultation on disclosure of industry payments to the healthcare sector. The consultation seeks views on the possible introduction of new secondary legislation. This legislation would place a duty on manufacturers and commercial suppliers of medicines, medical devices and borderline substances to report details of the payments and other…
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September 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 28 Aug)

Please note this is an extract of the original bulletin. Three new UK Approved Bodies to certify medical devices announced by the MHRA Page summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new UK Approved Bodies, almost doubling the UK’s capacity to certify medical devices, supporting faster certification of safe and effective medical devices for healthcare…
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September 8, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Publication of the MDR and IVDR Communication Survey (deadline September)

The European Commission recently launched a “MDR and IVDR Communication Survey” as part of their “Communication campaign on MDR and IVDR(HS-p-22-19.04, 06, 07, 08, 09, 10 and 11)”. The objective of the survey is to better understand the information needs around the MDR and IVDR, how the changes in the legislation are affecting directly involved stakeholders, and what challenges stakeholders…
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September 1, 2023
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