MT · S.L. 427.16
Diagnostic Medical Devices (S.L. 427.16)
Inhalt
- Art. 1 that, when compromise, the safety or property. Any when weighed of protection
- Art. 2 construction the generally solutions, the design and to risks of the
- Art. 3 that they are by the the art. They in terms of diagnostic of known The must be or available
- Art. 4 and 3 of this or the safety compromised the device is use. When no expected of a use of
- Art. 5 a way that be adversely etc.) taking
- Art. 8 to use it safely users, on the label to use the or, where unit is not and, or in the of one for use are the label into States, the label must in which the the form of the harmonised used must considered as and the and labelling † shall apply. itself or on and the other for use. regulations and subst
- Art. 6 application or and to be carried out in view of its label and its conforms with an EC to be with the contain the needed for of the the EC design- design. notified body changes could or with the shall take the
- Art. 7 secrecy vis-a-vis the competent carried out) effect. The following For the background in - if -