Memorandum from the Department of Health
MEDICAL DEVICES REGULATIONS 2002 (S.I. 2002/618)
- The Committee has request a memorandum on two points relating the to the Medical Devices Regulations 2002.
(1) Explain the inclusion of the words "unless the context otherwise requires" in regulations 2(1), 5(1) and (2), 20(1) and (2), 32(1) and (2), 52(1), and 59 by identifying the context in which the expressions defined or referred to are intended to bear a different meaning.
- Regulations 2(1), 5(1), 20(1), 32(1), 52(1) and 59 all contain expressions that, in some way, relate to obligations under the Directives implemented by the Medical Devices Regulations 2002. The precise nature of these obligations is often unclear, and the Department has sought to use language in the Regulations that enables the Regulations to be read with the flexibility that the courts may, in due course, require in order to clarify what the Directives - and thereafter the Regulations - require. The use of the expression "unless the context otherwise requires" was to acknowledge these difficulties on the face of the Regulations.
- However, the Department accepts that the uses of the expression "unless the context otherwise requires" in regulations 5(2), 20(2), 32(2) (which relate to numbering systems) were unnecessary and should have been omitted. The Department will ensure, when the next consolidated version of the Regulations is produced, that the expression "unless the context otherwise requires" will no longer be used in these provisions.
(2) In regulation 20(2), explain the relevance of the reference to "a numbered article", given that Part III contains no such reference.
- This, unfortunately, is a mistake, which the Department will rectify when the next consolidated version of the Regulations is produced.
26th June 2002