Regulatory Affairs Newsletter – Page 166

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CLSI publishes EP33, 2nd Edition, Use of Delta Checks in the Medical Laboratory

CLSI has published guidelines on the use of delta checks in the medical laboratory. It details different approaches for validation of measurements for which delta checks are useful. It outlines the procedures to determine delta check limits and regulations for comparing current clinical results with previously reported outcomes for a specific patient. It also covers the steps involved in initiating…

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HM Customs & Revenue weekly update (WC 03 July)

Please note this is an extract of the original bulletin. Check if you can claim a waiver for goods brought into Northern Ireland Page summary: You may be able to claim a waiver for goods brought into Northern Ireland so that you do not have to pay duty on those goods. Change made: First published. Time updated: 1:00pm, 3…

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OPSS weekly update (WC 03 July)

Please note this is an extract of the original bulletin. Designated standards: new or amended notices of publication Page summary: Proposed updates to the lists of standards for businesses. Change made: Proposals to amend added for personal protective equipment (PPE) and pressure equipment.

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APHA weekly update (WC 03 July)

Please note this is an extract of the original bulletin. Import risk categories for animals and animal products imported from the EU to Great Britain, from 31 October 2023 Page summary: Import risk categories under the Border Target Operating Model (TOM) for animals or animal products you’re importing from the EU to Great Britain (England, Scotland and Wales), and the…

adminJuly 14, 2023

DEFRA weekly update (WC 03 July)

Please note this is an extract of the original bulletin. Antimicrobial resistance (AMR) Page summary: Information and resources on the UK’s plans to see antimicrobial resistance contained and controlled by 2040. Change made: Added updated links. Genetically modified organisms: applications, decisions and notifications Page summary: Information about releases of genetically modified organisms (GMOs) for research purposes, including lists of applications,…

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DBT weekly update (WC 03 July)

Please note this is an extract of the original bulletin. Training on export control compliance Page summary: Courses, seminars, workshops and webinars to help exporters understand their obligations under export control legislation. Change made: Updated the information for some of the training courses to reflect that they are fully booked.

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MHRA weekly update (WC 03 July)

Please note this is an extract of the original bulletin. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or…

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DHSC MedTech and Crown Commercial Service Energy Webinar for Suppliers

The DHSC Medical Technologies Directorate is hosting a webinar regarding energy alongside the Crown Commercial Service on Wednesday 19 July 2023 at 14:00 – 15:00 The webinar will include sessions by John Moors who has been working as the Customer Specialist Lead for Energy within the Crown Commercial Service. He will be presenting on: Energy Supply Contracts for Industry UK…

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DSIT weekly update (WC 03 July)

Please note this is an extract of the original bulletin. AI Council Page summary: An update on the AI Council. Change made: First published. DSIT cyber security newsletter Page summary: A monthly newsletter detailing the latest DSIT announcements, events and projects for people interested in the field of cyber security. Change made: We have added the June 2023 edition of…

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European Commission published update on EU reference labs

The European Commission has provided an update on the designation of EU reference labs. Reference labs are intended for high-risk medical devices and should be a part of the conformity assessment process. There are currently no reference labs designated for the IVDR. In July 2022, the European Commission opened applications to become a reference lab, specifically under 8 categories: Hepatitis…

adminJuly 7, 2023