Regulation 5 Amendment of regulation 8 of the principal Regulations

In regulation 8 of the principal Regulations (essential requirements for general medical devices), after paragraph (2) add—

“(3)

Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Annex I to Directive 2006/42 to the extent to which those essential health and safety requirements are more specific than the essential requirements to Directive 93/42.”.