Traduction de «assemblatrice di dispositivi medici » (Italien → Anglais) :

medical furniture maker | medical instrument assembly worker | medical device assembler | medical device fabricator

medical device inspector | technician in medical equipment | medical device engineering technician | technician in medical devices

Scientific Committee on Medicinal Products and Medical Devices

Advisory Committee on the approximation to the laws of the Member States relating to medicinal devices

Working Party on Pharmaceuticals and Medical Devices

medical device testing methods | test procedures for medical devices | medical device test procedures | procedures for testing medical devices

(42b) As this Regulation now combines active implantable medical devices covered by Directive 90/385/EEC, and implantable medical devices covered by Directive 93/42/EEC, and places all active implantable medical devices and implantable devices of public health concern in the highest risk class III category attracting the strictest controls, and as the vast majority of class IIb implantable medical devices such as pins, bone-screws, plates, staples etc., have a long history of safe implantation within the human body, and as special notified bodies will be specifically designated for such class IIb implantable devices, class IIb implantabl ...[+++]e devices need not be subjected to the scrutiny procedure.

6a. This Regulation now combines active implantable medical devices covered by Directive 90/385/EEC, and implantable medical devices covered by Directive 93/42/EEC, and places all active implantable medical devices and implantable devices of public health concern in the highest risk class III category attracting the strictest controls, and as the vast majority of class IIb implantable medical devices such as pins, bone-screws, plates, staples etc., have a long history of safe implantation within the human body, and as special notified bodies will be specifically designated for such class IIb implantable devices, class IIb implantable dev ...[+++]ices need not be subjected to the scrutiny procedure.

(55) An expert committee, the Medical Device Coordination Group ( MDCG) , composed of persons designated by the Member States, based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices, should be established in accordance with the conditions and modalities defined in Article 78 of Regulation (EU) [Ref. of future Regulation on medical devices] on medical devices to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) [Ref. of future Regulation on medical devices] on medical devices, to provide advice to the Commission and to assist the Commission and the Member States i ...[+++]n ensuring a harmonised implementation of this Regulation.

For the purposes of this Regulation, medical devices, accessories to medical devices and devices for aesthetic purposes shall hereinafter be referred to as ‘devices’.