Please note this is an extract of the original bulletin.
Timeframe for accepting CE marked medical devices in Great Britain extended
Page summary:
CE marked medical devices will continue to be accepted on the Great Britain market beyond 30 June 2023
Change made:
First published.
Register medical devices to place on the market
Page summary:
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Change made:
This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
Register medical devices to place on the market
Page summary:
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Change made:
Increase in registration fees, effective immediately. Updated reference guides.
Medical devices: software applications (apps)
Page summary:
Information on when software applications are considered to be a medical device and how they are regulated.
Change made:
Updated file ‘Medical device stand-alone software including apps (including IVDMDs)’ to reflect that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
Clinical trials for medicines: apply for authorisation in the UK
Page summary:
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Change made:
New section about In Vitro Diagnostic Medical Devices (IVDs) has been included.
Medical devices regulations: compliance and enforcement
Page summary:
Information on MHRA’s enforcement duties and how to report a non-compliant medical device.
Change made:
This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
Approved bodies for medical devices
Page summary:
Guidance on what approved bodies are, what they do and how you can become one.
Change made:
This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
Medical devices: off-label use
Page summary:
What is considered off-label use of a medical device and examples of it.
Change made:
This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
Assistive technology: definitions, examples and safe use
Page summary:
Helps manufacturers and healthcare professionals understand the definition of assistive technology and the difference between medical devices and aids to daily living.
Change made:
This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
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 ‘For industry and manufacturers: COVID-19 tests and testing kits’ was updated to reflect that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
Regulating medical devices in the UK
Page summary:
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Change made:
This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023
Implementation of medical devices future regime
Page summary:
We are aiming for core aspects of the future regime for medical devices to apply from 1 July 2025.
Change made:
This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023
Virtual manufacturing of medical devices
Page summary:
Guidance for manufacturers who don’t design or manufacture devices but place their names on the product.
Change made:
This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
Borderlines with medical devices and other products in Great Britain
Page summary:
Guidance on whether or not your product is a medical device.
Change made:
File ‘updated in light of the extension of acceptance of CE marked devices on the GB market’ updated in light of the extension of acceptance of CE marked devices on the GB market.
MHRA People Strategy 2023 to 2026
Page summary:
This People Strategy sets out the agency’s five core priorities over the next three years.
Change made:
First published.
MHRA puts supporting patient access to innovation at the heart of its new Corporate Plan 2023-26
Page summary:
A new, visionary Corporate Plan, setting out how the Medicines and Healthcare products Regulatory Agency plans to keep patients safe by enabling access to innovative, safe and effective medical products over the coming three years, has been published today (4 July 2023).
Change made:
First published.
MHRA equality objectives: 2023 to 2027
Page summary:
These equality objectives set out how the Medicines and Healthcare products Regulatory Agency (MHRA) will comply with the public sector equality duty.
Change made:
First published.
MHRA Corporate Plan 2023 to 2026
Page summary:
This plan outlines the agency’s strategic direction over the next three years.
Change made:
First published.
Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
Page summary:
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
Change made:
This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
