Medical Device Regulatory Requirements in United Kingdom
| Regulatory Authority |
Medicines and Healthcare products Regulatory Agency (MHRA) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
EUMDR-2017/745
| Click Here
|
| Registration Process |
Register medical devices to place on the market
| Click Here
|
| Registration Timeline |
MHRA takes 5 working days to review the application. |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in English Language |
| Database |
Public Access Registration Database (PARD)
| Click Here
|
| Adverse Event Reporting Form |
Download |
| Additional Information |
Medical devices placed on the Great Britain market must have a UKCA marking or a CE marking, depending on which legislation the device has been certified under. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025