admin – Page 71 – BIVDA Newsletter

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

MHRA weekly update (WC 17 July)

Please note this is an extract of the original bulletin. In vitro diagnostic medical devices: guidance on legislation Page summary: Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices Change made: In vitro diagnostic medical devices: guidance on legislation file updated. How tests and testing…

adminJuly 28, 2023

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

HSE publications WC 24 July

HSE have published their latest bulletins: Biocides 24 July: Upcoming GB active substance renewal submission deadlines: Apply for active substance renewal by the deadlines to keep products on the GB market Under the GB BPR, active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date. The 550-day deadlines are coming…

adminJuly 28, 2023

Membership News Membership News Archive Regulatory Affairs Newsletter UK Government Updates Environmental Newsletter Archive UK Government Updates Regulatory Affairs Newsletter

Draft post-market surveillance statutory instrument published on WTO website

The draft statutory instrument for post-market surveillance requirements under the new UKCA regime has been published on the World Trade Organisation website. The notification can be found here. The draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 is applicable to Great Britain only. It introduces a new part, Part 4A, which defines the post-market surveillance requirements of…

adminJuly 28, 2023

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

DEFRA update on packaging EPR fees

DEFRA have confirmed that the Extended Producer Responsibility (EPR) for packaging fees have been deferred to one year. The one year delay is confirmed in the EPR guidance. This will apply from October 2025.

adminJuly 28, 2023

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

DESNZ weekly update (WC 17 July)

Please note this is an extract of the original bulletin. Net Zero Innovation Portfolio Page summary: The Net Zero Innovation Portfolio provides funding for low carbon technologies and systems, to help enable the UK to end its contribution to climate change. Change made: Updated with links to competition successful projects.

adminJuly 28, 2023

APHA weekly update (WC 17 July)

Please note this is an extract of the original bulletin. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Updated BCP council’s contact details in the list of professionals in England.…

adminJuly 28, 2023

Office for Life Sciences – publications (WC 24 July)

The Office for Life Sciences have published their latest updates. OLS Bulletin - 24 July These include updates on news, including regulatory updates, transitional guidance and events.

adminJuly 28, 2023

OPSS weekly update (WC 17 July)

Please note this is an extract of the original bulletin. Approved verification: guidance and application form Page summary: Weights and Measures Act 1985 and subsequent Deregulation Order 1999 (as amended). Change made: Register of approved verifiers updated. OPSS enforcement actions Page summary: Enforcement actions from 1 April 2018 to 31 March 2023. Change made: OPSS enforcement actions 1 October to…

adminJuly 28, 2023

UK Government Updates Regulatory Affairs Newsletter UK 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…

adminJuly 21, 2023

UK Government Updates Regulatory Affairs Newsletter UK 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.…

adminJuly 21, 2023