Health and Safety (Medical Devices) Regulations (Northern Ireland) 1996

Explanatory Note

(This note is not part of the Regulations.)

1.  These Regulations amend the Provision and Use of Work Equipment Regulations (Northern Ireland) 1993 by adding a new paragraph to Schedule 1 to those Regulations. Items of work equipment provided for use in the premises or undertaking of an employer must comply with any statutory provision which implements in Northern Ireland any of the relevant Community Directives listed in Schedule 1 which is applicable to such items of work equipment. The new paragraph adds to the list of relevant Community Directives contained in Schedule 1 a reference to the Medical Devices Directive, Council Directive 93/42/EEC (O.J. No. L169, 12.7.93, p. 1).

2.  The Regulations also amend the Personal Protective Equipment at Work Regulations (Northern Ireland) 1993 (“the PPE Regulations”) by substituting a new Schedule for the present Schedule 1. The PPE Regulations, inter alia, specify the circumstances in which suitable personal protective equipment must be provided for use by employees and the self-employed and the minimum conditions of what is “suitable”. These conditions include that the equipment must comply with any statutory provision which implements in Northern Ireland any provision on design or manufacture with respect to health and safety in any relevant Community Directive listed in Schedule 1 to the PPE Regulations which is applicable to that item of equipment. The new Schedule 1 updates the reference to Council Directive 89/686/EEC to take account of its amendment by later Directives and adds a reference to the Medical Devices Directive.