BIVDA response: MHRA Consultation on the future regulation of medical devices in the United Kingdom ConsultationsConsultations Archive

BIVDA response: MHRA Consultation on the future regulation of medical devices in the United Kingdom

The BIVDA response to the MHRA consultation on the future regulation of medical devices in the United Kingdom was submitted on 25th November 2021. Please find below this full response, along with the cover letter which was submitted to MHRA on 26th November 2021. Consultation response  
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February 18, 2022
New Proposals on the future of UK Clinical Trial Legislation Consultations Archive

New Proposals on the future of UK Clinical Trial Legislation

The Medicines and Healthcare products Regulatory Agency (MHRA) have published a consultation on proposals for legislative changes for clinical trials. The consultation aims to amend the existing requirements for clinical trials in the UK, regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended. Any amendments are intended to streamline approval of clinical trials, enable innovation, enhance…
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February 18, 2022
BIVDA response: UK Health Security Agency consultation on UK SMI S 12: sepsis and other systemic and disseminated infections Consultations Archive

BIVDA response: UK Health Security Agency consultation on UK SMI S 12: sepsis and other systemic and disseminated infections

The consultation asked for feedback on UK Standards for Microbiology Investigations S 12: sepsis, and other systemic and disseminated infections. This consultation ran from 15 November 2021 to 5pm on 29 November 2021. Consultation response
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December 3, 2021
BIVDA response: GMDN Agency Consultation on specific IVD related GMDN terms Consultations Archive

BIVDA response: GMDN Agency Consultation on specific IVD related GMDN terms

The IVD Team at the GMDN Agency launched a consultation regarding a proposed scaling back of antibody-specific IVD terms within the GMDN. The move would be to consolidate all infectious disease antibody-class specific terms for a particular analyte to a single concept, including total antibody and neutralizing antibody concepts. Consultation response
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December 3, 2021
Consultation on the diagnosis and management of type 1 diabetes in adults Consultations Archive

Consultation on the diagnosis and management of type 1 diabetes in adults

A new consultation concerning the diagnosis and management of type 1 diabetes in adults has been launched by NICE following a review of current evidence. A number of existing recommendations on diagnosis and continuous glucose management have been replaced. Other recommendations have been moved or updated to reflect these alterations. If you wish to respond, please submit your feedback here…
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November 26, 2021
Consultation on glucose monitoring in children and young people with diabetes (type 1 and type 2) Consultations Archive

Consultation on glucose monitoring in children and young people with diabetes (type 1 and type 2)

NICE has issued a consultation on glucose monitoring in children and young people with diabetes (type 1 and 2) following a review of the latest evidence. Existing recommendations pertaining to continuous glucose monitoring have been replaced by new recommendations, while other recommendations have been updated to reflect these changes. Members are encouraged to respond to this consultation here (https://www.nice.org.uk/guidance/indevelopment/gid-ng10266/consultation/html-content) before…
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November 26, 2021
Consultation on Type 2 diabetes in adults: management – glucose monitoring Consultations Archive

Consultation on Type 2 diabetes in adults: management – glucose monitoring

BIVDA is seeking input from members regarding NICE’s consultation on glucose monitoring in adults with type 2 diabetes. The consultation specifically concerns the addition of new recommendations on continuous glucose monitoring for adults with type 2 diabetes following a review of the latest evidence. Other recommendations have been updated to reflect these changes. The consultation can be found here (https://www.nice.org.uk/guidance/indevelopment/gid-ng10264/consultation/html-content).…
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November 26, 2021
UK Health Security Agency – sepsis consultation AMR TaskforceAMR Taskforce ArchiveConsultations Archive

UK Health Security Agency – sepsis consultation

Closing: 29/11/2021 New Consultation: UK SMI S 12: sepsis and other systemic and disseminated infections | See here BIVDA is seeking company input members of the AMR working party to respond on behalf of the sector. Please send your comments to Ashleigh no later than Wednesday 24 November COB. Please register for a Ad-Hoc AMR consultation response meeting with Doris-Ann…
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November 19, 2021
Consultation on specific IVD related GMDN terms Consultations ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Consultation on specific IVD related GMDN terms

The GMDN Agency have provided the summary information below. This is regarding a consultation on specific IVD related GMDN terms. The IVD Team at the GMDN Agency have launched a consultation regarding a proposed scaling back of antibody-specific IVD terms within the GMDN. The move would be to consolidate all infectious disease antibody-class specific terms for a particular analyte to…
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November 19, 2021