FROM THE JOINT COMMITTEE OF BOTH HOUSES APPOINTED TO SCRUTINISE STATUTORY INSTRUMENTS, ETC.
- The Committee has considered the instruments set out in the Annex to this Report and has determined that the special attention of both Houses does not require to be drawn to any of them.
MEDICAL DEVICES REGULATIONS 2002 (S.I. 2002/618)
- The Committee draws the special attention of both Houses to these Regulations on the ground that they are defectively drafted.
- Regulations 2(1), 5(1) and (2), 20(1) and (2), 32(1) and (2), 52(1) and 59 provide that, unless the context otherwise requires, certain expressions are to have the meaning ascribed or referred to in the provision in question. In a memorandum printed in the Appendix, the Department of Health acknowledges that the italicised words are unnecessary in relation to regulations 5(2), 20(2) and 32(2) and should have been omitted, since there is no context in which a different interpretation is required. It undertakes to omit those words when the Regulations are next consolidated. However, in relation to the other provisions, the Department explains that they contain expressions which relate to obligations under the Directives being implemented by these Regulations; and, since the precise nature of those obligations is often unclear, the Department has sought to use language to enable the Regulations to be read with the flexibility that the courts may require in order to clarify what the Directives and hence the Regulations may require. The use of the expression "unless the context otherwise requires" was intended to acknowledge these difficulties on the face of the Regulations. Whilst following the first part of this explanation, we do not accept that the stated aim can properly be achieved by incorporating the words in question. Given that the expressions are being defined for the purposes of the Regulations, the insertion of the words "unless the context otherwise requires" would only be justifiable if an identifiable context in the Regulations required a different meaning to be given to one or more of the defined expressions. The Department has provided no example where the context requires a different meaning to be given to the defined expressions. The Committee reports regulations 2(1), 5(1) and (2), 20(1) and (2), 32(1) and (2), 52(1) and 59 for defective drafting, partially acknowledged by the Department.
- Regulation 20(2) is defectively drafted in another respect. It provides that in Part III of the Regulations a reference to a numbered article or Annex is to the article or Annex of Directive 90/385 bearing that number. The Department acknowledges that the inclusion of this provision is an error, since Part III contains no such reference. It undertakes to rectify this error when the Regulations are next consolidated. The Committee reports regulation 20(2) for defective drafting, acknowledged by the Department.
1 The Orders of Reference of the Committee are set out in the First Report, Session 2001-02 (HL Paper 7; HC 135-i). Back