MDCG Solutions: Notified Body Capacity & Manufacturer Readiness
26 August 2022
MDR/IVDR Manual on Borderline and Classification Released
7 September 2022Today 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)
