Memorandum by the Department of Health
MEDICAL DEVICES FEES (AMENDMENT) REGULATIONS
1997 (S.I. 1997/694)
1. The Committee requested a Memorandum by its letter of
6 June 1997 on the following point:
Explain the reasons for the increase in fees made
by regulation 2.
2. The activities for which the Medical Devices Agency charges
fees relate to the assessment for the purposes of designation
or change of status of independent certification organisations
known as notified bodies and assessment of notifications of clinical
investigations of medical devices (both statutory responsibilities).
It is one of the Agency's business targets that the full costs
of carrying out these assessments be covered by fees payable by
the certification organisations and manufacturers.
3. The fees charged under the principal Regulations were
based on estimates of the amount of time it would take to carry
out each type of assessment. Since these duties were new to the
MDA there was no evidence as to how long the tasks would take
in practice. Since the implementation of the principal Regulations,
monitoring of the tasks performed has revealed that in practice
the time taken to perform most tasks and the associated overhead
costs have been higher than those estimated.
4. The new fees payable under regulation 2 adjust the fees
payable to reflect better the actual cost of each type of activity.
This accounts for the variation in the rate of the increase and
for the fact that some fees have remained unchanged. The figures
also allow for 5% forecast of inflation of MDA's own costs in
the year 1997-98.
12th June 1997