Joint Committee on Statutory Instruments Third Report


APPENDIX I

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


 
previous page contents next page
House of Lords home page Parliament home page House of Commons home page search page enquiries

© Parliamentary copyright 1997
Prepared 29 July 1997