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

MHRA weekly update (WC 14 Aug)

Please note this is an extract of the original bulletin. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: Published updated ‘COVID-19 test validation approved products’ data. 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…
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August 25, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA designates new UK Approved Bodies for Medical and IVD devices

The MHRA have increased their capacity to process conformity assessments for medical and IVD devices with the addition of TUV Rheinland UK Ltd and TUV SUD BABT Unlimited to their existing list of UK Approved Bodies. Approved bodies are organisations which the MHRA have designated to assess whether manufacturers and their medical devices meet the requirements set out in the UK…
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August 18, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 07 Aug)

Please note this is an extract of the original bulletin. How tests and testing kits for coronavirus (COVID-19) work Page summary: The different types of tests and testing kits for COVID-19, and the specifications for manufacturers. Change made: The guidance on performing variant analysis for manufacturers of SARS-CoV-2 screening and diagnostic assays has been updated. Updated guidance documents are included…
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August 18, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 31 July)

Please note this is an extract of the original bulletin. CE marking recognition for medical devices and in vitro diagnostics Page summary: The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics. Change made: First published. Medical devices: guidance for manufacturers on vigilance Page summary: Information for manufacturers…
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August 11, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 24 July)

Please note this is an extract of the original bulletin. Medical devices: guidance for manufacturers on vigilance Page summary: Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA. Change made: Guidance updated to reflect the latest information regarding the MORE portal. COVID-19 test validation approved products Page summary: Find out which…
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August 4, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Extension of CE mark recognition in Great Britain for certain products

The UK Government have announced that recognition of the CE mark for most goods will be continued indefinitely, beyond December 2024. This applies only to the 18 regulations falling under the Department for Business and Trade (DBT), covering a range of products: toys pyrotechnics recreational craft and personal watercraft simple pressure vessels electromagnetic compatibility non-automatic weighing instruments measuring instruments measuring…
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August 4, 2023
UK Government Updates Regulatory Affairs NewsletterUK 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…
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July 28, 2023
UK Government Updates Regulatory Affairs NewsletterUK 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…
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July 21, 2023
UK Government Updates Regulatory Affairs NewsletterUK 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.…
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July 21, 2023
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