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Regulations, including those transposed in each of the member
states, e.g. language requirements. With full compliance a
manufacturer is then able, where applicable, to affix a CE mark
demonstrating compliance with the essential requirements of the
Directive. The Medical Devices Directive and the application of
the CE mark was a legal requirement for all manufacturers with
effect from 14th June 1998, following a 5-year transition period.
Within the United Kingdom and Northern Ireland responsibility
for the enactment and compliance with the Medical Devices
Directives has been assigned to the Medicines and Healthcare
products Regulatory Agency {(MHRA) (Competent Authority
– CA)}, working in conjunction with the respective devolved
administrations of Northern Ireland, Scotland and Wales. The
CA for Ireland is the Irish Medicines Board, Medical Devices
Department.
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