Initial consultation for a Device which incorporates one or more known medicinal substances from an approved manufacturer of that substance£4,550 Further consultation of a Device which incorporates one or more known medicinal substances from an approved manufacturer of that substance£900 Initial consultation for a Device which incorporates one or more known medicinal substances from a new source£10,604 Further consultation of a Device which incorporates one or more known medicinal substances from a new source£2,451 Initial consultation for a Device which incorporates a new active substance£46,526 Further consultation of a Device which incorporates a new active substance£11,551 Notes:
if a device incorporates two or more medicinal substances the fee will be for the higher priced substance.
the same fee applies regardless of the strength or concentration of the medicinal substance.
one fee will apply to multiple applications made at the same time for a range of similar devices (e.g. a range of catheters made of the same material) incorporating the same medicinal substance at the same level.
Conformity Assessment Body Designation Applications
Extension to scope, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and where the Secretary of State considers that an additional assessment of the body’s procedures is required.£18,212 Extension to scope, to carry out tasks under Part 2, Part 3 or Part 4, which extends the body’s designation in relation to a Part under which they have already been designated.£12,571 Subsidiary audit* subject to additional fees calculated by hourly rate and travel rates (covers both Approved Body and Notified Body)£22,789