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(This note is not part of the Regulations)
These Regulations amend the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the principal Regulations”). The principal Regulations prescribe the fees which are payable where a notified body consults the competent body in accordance with Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
Regulation 2 amends regulation 3 of the principal Regulations by reducing the amounts of all the fees specified in that regulation. Therefore an assessment of the cost to business of complying with these Regulations has not been made.
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