Notifying changes to MHRA
Change notification obligations derive from UK MDR 2002 registration provisions and MHRA's registration guidance. Significant device changes may also require UKAB notification under Schedule 3 conformity assessment conditions.
Changes requiring MHRA notification (beyond registration update)
Some changes are not just registration administrative updates — they represent substantive changes that MHRA should be aware of:
Significant device changes
A significant change to a device design, intended purpose, materials, software, or manufacturing process may:
- Require technical file update
- Require UKAB assessment or notification (if the device is UKAB-certified)
- Require a new or revised Declaration of Conformity
- Require MHRA registration update
The manufacturer must assess the significance of the change against the Essential Requirements. If the change is material to the device's safety or performance, MHRA registration must reflect the updated device, and the UKAB must be notified per the terms of the certificate.
FSCA and recall
As described in When an FSCA is required, FSCAs must be notified to MHRA within 10 calendar days of the FSCA decision — this is separate from registration update.
Serious incidents
Serious incidents must be reported to MHRA via the vigilance system — separately from registration update.
UKAB notification for certified devices
For Class IIa, IIb, III, AIMD, IVD List A, and List B devices certified by a UKAB, the manufacturer must also notify the UKAB of any significant changes to the device or quality management system. The UKAB's certificate conditions specify what constitutes a notifiable change.
Failure to notify the UKAB of a significant change may result in certificate suspension.
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 3 | Conformity assessment conditions — UKAB notification |
| MHRA: Registering medical devices | Change notification guidance |