The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
These Regulations (“the Regulations”) amend the Active Implantable Medical Devices Regulations 1992 (“the principal Regulations”) which implement Council Directive 90/385/EEC (OJ No. L 189, 20.7.90, p. 17) (“the active implantable medical devices Directive”). The Regulations implement those provisions in Council Directive 93/42/EEC (OJ No. L 169, 12.7.93, p. 1) (“the medical devices Directive”) which amend the active implantable medical devices Directive. The Regulations also implement in part Council Directive 93/68/EEC (OJ No. L 220, 30.8.93, p. 1) (“the CE marking Directive”) which amends a series of directives on technical harmonisation and standards which includes the active implantable medical devices Directive. The Regulations also make certain other minor amendments to the principal Regulations.