Consultations Archive

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…

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

The Government requested feedback in relation to the technical application of these regulations ahead of the introduction of Plastic Packaging Tax from 1 April 2022. This consultation ran from 4 November 2021 to 11:45pm on 1 December 2021. Consultation response

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

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…

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 Existing recommendations pertaining to continuous glucose monitoring have been replaced by new recommendations, while other recommendations have been updated to reflect these changes.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…

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).…

The MHRA has launched the public consultation on the future medical devices regime, with survey responses requested from industry stakeholders. BIVDA’s Regulatory Affairs Working Party has a sub-group dedicated to UKCA matters and will be working on an industry response to the consultation. Members are advised to submit their own responses independently as a priority. The consultation closes at 11:45pm…