Understanding the New Regulations on Medical Device and Blood Safety Fees

In a bid to update the fees associated with the regulation of medical devices and blood components for transfusion, the UK government has introduced a new set of regulations, known as The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025. This legislation, prepared by the Medicines and Healthcare products Regulatory Agency (MHRA), is crucial for ensuring that the agency can continue to provide effective regulatory services without financial shortfalls.

Key Changes in the Legislation:

1. Fee Adjustments:

   • The primary change involves adjusting existing fees to reflect the increased costs of regulatory activities. This adjustment ensures that the MHRA can recover all costs associated with its operations, preventing the need for government or taxpayer subsidies.

2. New Fees for Advisory Services:

   • A new fee has been introduced for optional regulatory advice meetings specifically for medical devices. This service aims to assist manufacturers, especially those dealing with complex or novel products, in understanding how UK regulations apply to their products.

3. Support for Small and Medium Enterprises (SMEs):

   • Recognizing the financial pressures on smaller businesses, the legislation introduces a payment easement for SMEs, allowing them to pay clinical investigation fees in two installments.

Why These Changes Are Important:

• Financial Sustainability: By updating fees, the MHRA ensures it can maintain financial sustainability, allowing it to continue safeguarding public health effectively.
• Encouraging Innovation: The optional advisory service is designed to help companies navigating the complex regulatory landscape, potentially accelerating the development of innovative medical products.
• Supporting SMEs: The easing of payment conditions for SMEs reflects an understanding of the unique challenges faced by smaller firms, supporting their contributions to the health sector.

Impact on Stakeholders:

• Businesses and Healthcare Providers: The overall impact on businesses, charities, and voluntary bodies is projected at an additional £0.7 million per year, post-inflation. For public sector bodies, which contribute a smaller portion of the MHRA's income, the impact is expected to be minimal.
• Ongoing Fee Monitoring: The MHRA plans to continue reviewing fees periodically to ensure they remain fair and reflective of actual service costs, balancing the need for cost recovery with the financial realities of stakeholders.

Consultation and Implementation:

• A public consultation, including a webinar for SMEs, was conducted to gather feedback on the proposed changes. The responses influenced the decision to implement a fees uplift while reconsidering other proposals, such as a new registration fee for medical devices.

Overall, these amendments aim to bolster the MHRA's capacity to regulate medical devices and blood components effectively, ensuring that UK citizens have access to safe and innovative healthcare solutions. The changes are set to take effect in early 2025, with updated guidance to be published before implementation.