The Medical Devices Directives are based on compliance with Essential Requirements.
Manufacturers can demonstrate compliance with a number of Essential Requirements by compliance with Harmonised Standards under each Directive. Please note that the lists contain both technical and systems related standards. The lists of these can be found on the European Commission website (click on the Directive title to obtain the list).
In a similar manner, compliance with the Common Technical Specifications (CTSs) for the most critical IVDs (those listed in Annex II, list A of the Directive) will ensure compliance with the appropriate device related Essential Requirements. The CTSs can be found on the European Commission website.
Where no harmonized standards are available other international, european and national standards may be taken into consideration. Where none of these are available then the manufacturers’ own in house test requirements and specifications will be key.
