BS TH 42076

For all medical devices regulated in the EU, this book provides CE marking information for products falling under the scope of the Medical Devices, the related Active Implantable Medical Devices and In-Vitro Diagnostic Medical Devices Directives. Includes: Equipment included in and excluded from the Directives; How to comply with the conformity procedures; The Technical Construction File and its contents; Hazard and risk assessment; CE marking requirements; How to complete the declaration forms (including examples); Quality system requirements; Copy of the Medical Devices Directives 93/42/EEC, 90/385/EEC and 98/79/EC; Copies of the amending Directives; A list of all current harmonized medical devices standards for each Directive.