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Decision: Medical devices given exceptional use authorisations during the COVID-19 pandemic

Medicines Healthcare Products Regulatory Agency

April 4
15:54 2023

Details

To ensure transparency around the supply of medical devices in the UK, we are now providing a list of manufacturers and devices granted an exceptional use application. We also provide a list of recently expired, withdrawn or cancelled authorisations for a 2 month period.

Medical devices granted an exceptional use authorisation can be sold to the NHS and within the social care setting to ensure a continued supply of medical devices.

Exceptional use authorisations will be issued directly to the manufacturer of the medical device and normally do not allow for distributor sales.

We only consider applications where there is a clear clinical need and there is no available supply of CE marked or already derogated alternatives.

An updated list (if there are any changes to report) will be published weekly to reflect any new, withdrawn or expired applications.

Published 29 June 2020
Last updated 4 April 2023 +show all updates
  1. Updated 'List of medical devices that are no longer covered by an exceptional use authorisation'

  2. Added HeartWave Inc (Medtronic Ltd) HVAD Controller to the New medical devices given exceptional use authorisations list.

  3. New medical devices given exceptional use authorisations added. Rocket Medical Plc - R54411 IPC Dressing Pack and 1000ml Bottle extension issued.

  4. Removed the following from Open List:DEU/010/2022/003 - ESCO Medical Technologies UAB (IVF Synergy) - CultureCoinDEU/003/2022/001 - Hunter Scientific Ltd - Pure Sperm WashDEU/005/2022/006 - Smiths Medical ASD, Inc.

  5. List of medical devices given exceptional use authorisations updated to include Biosense Webster Inc - SOUNDSTAR eco 8F Diagnostic Catheter and Abbott Diagnostics Scarborough Inc - COVID-19 Swab Transport Tube Accessory Pack (Catalogue code 190-010). ESCO Medical Technologies UAB (IVF Synergy) - CultureCoin, Hunter Scientific Ltd - Pure Sperm Wash and Smiths Medical ASD, Inc. - DI-50, DI-100,DI-300: Level 1 Normothermic I.V. Fluid Administration Set intended for use with Level 1R H-1000, H-1025, H-1028, and H-1200 Fast Flow Fluid Warmers only were added to 'no longer covered by an exceptional use authorisation' list.

  6. List of medical devices given exceptional use authorisations updated to include Medtronic Ltd - CapSure Epicardial Lead Model 4968. Extension issued until 31 July 2023 to Biosense Webster Inc - Various catheters and Bunzl Healthcare - Gauntlet Range Sterile Nitrile Examination Gloves (Medical). Extension issued until 1 August 2023 to Terumo Medical Corporation - FemoSealTM and Angio-SealTM Vascular Closure Devices. CryoLife Europa, Ltd BioGlue and Cooper Surgical, Inc. - Fetal Pillow, FP-010 were added to 'no longer covered by an exceptional use authorisation' list.

  7. Products were added to the open list from Rocket Medical plc and products were removed from Mercedes AMG HPP/UCL Hospital Trust UCL Ventura CPAP and Perspectum Ltd. Extensions were issued to Bunzl Healthcare and Gas Arc Ltd. A products was removed from the closed list from NVT GmbH (Biosensors International).

  8. Updated changes to the open list of medical devices given EUAs

  9. Update to 'List of medical devices given exceptional use authorisations'

  10. List of medical devices given exceptional use authorisations updated to include CliniMed Ltd Appeel - Sterile Range, Liquid

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