The Medical Devices Fees (Amendment) Regulations 1997

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Medical Devices Fees Regulations 1995 (“the principal Regulations”). The principal Regulations prescribe the fees payable in connection with the services provided by the Department of Health pursuant to the Secretary of State’s functions under Council Directives 90/385/EEC on the approximation of the laws of member States relating to active implantable medical devices (O.J. No. L189, 20.7.90, p. 17) (“the 1990 Directive”) and 93/42/EEC concerning medical devices (O.J. No. L169, 12.7.93, p. 1) (“the 1993 Directive”).

Regulation 2, by amending the Table of Fees set out in the Schedule to the principal Regulations, varies the fees payable for clinical investigations and applications from notified bodies. The fee for a notification of clinical investigation of a Group A (low risk) device is increased from £900 to £2,200 whilst the fee for a Group A re-notification is increased from £650 to £1,600. The fee for an application for designation as a notified body is increased from £1,300 to £2,600. The fee for a second or subsequent designation application made only to address the grounds for rejection of a previous application is increased from £400 to £650. The basic fee for an inspection of premises for the purpose of deciding whether or not the conditions specified in Annex 8 of the 1990 Directive or Annex XI of the 1993 Directive are fulfilled is increased from £2,700 to £3,200, whilst that for ensuring that the conditions continue to be fulfilled is increased from £1,600 to £2,600. The fee for the inspection of a manufacturer’s premises where the notified body is undertaking any task in relation to that manufacturer is increased from £1,600 to £2,600. The half day rate for inspections is increased from £160 to £185.

Regulation 3 increases from 5 days to 7 days the period (beginning with receipt of the notice) during which a person who withdraws his notice of intended clinical investigation is only required to pay fifty per cent of the fee otherwise payable.

A compliance cost assessment is available, copies of which have been placed in the libraries of both Houses of Parliament. Copies of the assessment are also available from the Medical Devices Agency, Hannibal House, Elephant and Castle, London SE1 6TQ.