Medical devices given exceptional use authorisations during the COVID-19 pandemic
Page summary:
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Change made:
Removed DEU/002/2021/001 (Numed Inc) & DEU/001/2024/001 (Inspire Medical Systems, Inc.) from Open list.Added DEU/001/2024/001 (Inspire Medical Systems, Inc.) to Closed list.
Time updated:
2:54pm, 21 October 2024
Implementation of medical devices future regime
Page summary:
A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition.
Change made:
On 21 October 2024, the draft Post-Market Surveillance statutory instrument was laid in Parliament. The new regulations will introduce clearer and more robust requirements for PMS that improve patient safety.
Time updated:
10:00am, 22 October 2024
Statutory Instrument laid in Parliament sets out first steps in delivering Medical Device Regulatory Reform and strengthening patient safety
Page summary:
The new legislation will introduce clearer and risk-proportionate requirements that improve the safety of medical devices across Great Britain and provide certainty for manufacturers ahead of introducing the wider future regulatory regime.
Change made:
First published.
Time updated:
10:21am, 22 October 2024
World Polio Day: MHRA trains worldwide laboratories in early detection of polio using breakthrough advanced technology
Page summary:
Medicines and Healthcare products Regulatory Agency (MHRA) is highlighting our work training multiple World Health Organisation (WHO) polio laboratories around the world.
Change made:
First published.
Time updated:
10:00am, 24 October 2024
Clinical investigations guidance
Page summary:
Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Change made:
Added link to ‘IRAS User Guide – Amendments’.
Time updated:
2:48pm, 25 October 2024
