Please note this is an extract of the original bulletin.
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:
Reference guides updated and new video tutorials added.
MHRA fees
Page summary:
Fees payable to the MHRA for 2023 to 2024
Change made:
Amendment fees added to our ‘Current MHRA fees’ webpage.
Export medical devices
Page summary:
Order a certificate of free sale to export medical devices outside the UK.
Change made:
Updated video tutorial for ‘How to order and reorder Certificates of Free Sale’
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:
Added link to ‘Guidance: Reporting adverse incidents involving Software as a Medical Device under the vigilance system’
Reporting adverse incidents involving Software as a Medical Device under the vigilance system
Page summary:
Information for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable.
Change made:
First published.
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’ to include information on the implementation of new regulations, updates to various links including MORE and new software vigilance guidance.
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:
Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain 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:
Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.
Medical devices: legal requirements for specific medical products
Page summary:
Guidance for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
Change made:
Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain 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:
Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.
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:
Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain 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:
Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain 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:
Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.
DEHP phthalates in medical devices
Page summary:
Information for manufacturers and users of medical devices containing plastic with DEHP phthalates.
Change made:
Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.
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 cancellation.
Change made:
Added ‘S.A.L.F. S.p.A. Laboratorio Farmacologico (aka S.A.L.F.) – Servator M ‘ to Open list. Moved ‘UnifAI – Covid-19 Digital Reader ‘ to the Closed list.
