delete The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023
These Regulations amend the Medical Devices Regulations 2002 and Blood Safety and Quality Regulations 2005 to substantially increase regulatory fees. Key changes include: new definitions for 'statistical review' and other terms; new provisions allowing manufacturers to request pre-submission meetings with the Secretary of State for regulatory advice and statistical review; massive fee increases ranging from 140% to over 330% for various medical device approvals, inspections, and consultations; new fees for pre-consultation scientific advice meetings (£824 to £1,813); and consultation fees for devices incorporating medicinal substances (up to £46,526 for new medicinal substances).
These regulations impose enormous fee increases (300-400% above previous rates) on medical device manufacturers without any apparent justification for such dramatic jumps. The regulations create a complex, bureaucratic fee structure that adds administrative burden while raising costs for businesses seeking to bring medical devices to market. Such steep fee increases act as barriers to entry, particularly for startups and smaller companies, reducing competition and innovation in a sector where diversity of suppliers serves public health. Post-Brexit, Britain should be reducing regulatory costs to attract medical device investment away from the EU and US, not inflating them. The substantial new charges for pre-consultation meetings and statistical reviews, while framed as helpful, create new friction points that slow device approvals. If regulatory oversight must be funded by fees, they should reflect actual costs of supervision, not serve as a revenue-raising mechanism disconnected from expenditure.