Background

In August 2024 the MHRA opened a consultation on its proposal to modify fees: HERE

Some of the proposed changes include:

• Introduction of an annual registration maintenance fee, to support the MHRA’s post-market activities. This would be charged per registered GMDN code, which could have a significant financial impact on manufacturers with a high number of registrations.
• Introduction of a ‘Regulatory Advice Meeting’ fee, in which the MHRA will provide “expert regulatory advice to medical device manufacturers”, in particular for “novel and/or complex products with the potential to significantly improve patient outcomes, where the application of the Regulations is not straightforward and easily understood”.
• Increase to clinical investigation fees.

The Update

The MHRA published the industry feedback they received, and their corresponding decision: HERE

Proposal 1: Increase to Clinical Investigation Fees

Note that Proposal 1 includes more than just medical device clinical investigation fees. See Annex B (starting page 22) for the full list of impacted fees, including drug-device combination products, homeopathic products, and more.

Regarding clinical investigations, the MHRA intends to proceed with the fee increase, as they “have calculated our fees as reasonable and justified given the quality and responsive service provided”.

In response to concerns regarding the impact on small-to-medium sized enterprises (SMEs), the MHRA will create a new SME payment easement. This easement will allow SMEs to spread the costs over two installments. The MHRA will provide more details on this “in due course”.

The new clinical investigation fees are as follows:

Fee Name	Current Fee	Proposed Fee
Clinical investigations for devices: fees – Amendment fees – High risk device amendment	£331	£361
Clinical investigations for devices: fees – Amendment fees – Low risk device amendment	£207	£226
Clinical investigations for devices: fees – Consultation – Clinical Investigations statistical review	£782	£852
Clinical investigations for devices: fees – Consultation – Device Regulatory Advice meeting	£906	£987
Clinical investigations for devices: fees – Notification of a clinical investigation – Class I, IIa, or IIb other than implantable or long-term invasive devices (Resubmission)	£5,711	£11,701
Clinical investigations for devices: fees – Notification of a clinical investigation – Class I, IIa, or IIb other than implantable or long-term invasive devices (Initial submission)	£7,472	£15,309
Clinical investigations for devices: fees – Notification of a clinical investigation – Class IIb implantable or long-term invasive, Class III, and active implantable devices (Resubmission)	£11,069	£22,678
Clinical investigations for devices: fees – Notification of a clinical investigation – Class IIb implantable or long-term invasive, Class III, and active implantable devices (Initial submission)	£15,627	£32,016

Proposal 2: Annual Registration Fees

The majority of respondents did not agree with the MHRA’s proposal to introduce this new annual £210 fee per registration. Potential repercussions include product withdrawals, resulting in fewer medical devices being available on the Great Britain market.

As a result, the MHRA decided not to pursue this fee for now. Instead, they will “continue exploring options on this fee”.

However, the registration fee for new applications will be increased from £240 to £261.

Proposal 3: Regulatory Advice Meeting Fee

As most respondents agreed with this proposal, the MHRA will proceed in introducing this new fee of £987.

More information will be published “in due course” to address some of the comments received, e.g., risks that the MHRA’s advice will contradict that of the Notified Bodies / Approved Bodies.

Timeline for New Fees

The implementation date for the fee changes is early Q1 2025/26. The MHRA’s fiscal year begins on 1 April 2025, i.e., Q1 2025/2026 is April 1, 2025 – June 30, 2025.