Today the MHRA published a public consultation related to increasing the agency’s fees.
The consultation is available: HERE
The proposed fee increase includes a variety of products, including pharmaceuticals. Please refer to the consultation for the full list of changes.
The below table only addresses the changes for medical device and IVD fees.
Fee Type | Current Fee | Proposed New Fee |
Medical Device & IVD: New Registration | £100 | £240 |
Medical Device & IVD: Registration Amendment | £100 | £240 |
Clinical Investigation Notification: Class I, IIa, or IIb other than implantable or long-term invasive devices | £3,820 | £7,472 |
Clinical Investigation Notification: Class I, IIa, or IIb other than implantable or long-term invasive devices: Notification – re-notification in the event of an objection | £2,920 | £5,711 |
Clinical Investigation Notification: Class IIb implantable or long-term invasive, Class III, and active implantable devices: Notification | £5,040 | £15,627 |
Clinical Investigation Notification: Class IIb implantable or long-term invasive, Class III, and active implantable devices: Notification – re-notification in the event of an objection | £3,570 | £11,069 |
The proposed implementation date for the new fees is 1 April 2023.
The consultation closes 23 November 2022.
For more information on the MHRA registration process, please read: UK Medical Device Registration
For more information on the UK Responsible Person, please read: Role of the UK Responsible Person (UKRP)