Directiva 93/13/cee pdf

This Directive applies to medical devices and their accessories. For the purposes of this Directive, accessories are treated as medical devices in their own right. Specimen receptacles are considered to be in vitro diagnostic medical devices.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;. Before proceeding with the assessment procedure, it is important to establish whether the manufacturer, can assess the product by itself or whether there is a need to involve a Notified Body.

The involvement of a Notified Body is not necessary for medical devices of Class I unless they have a measuring function or are placed on the market in a sterile condition. For all medical devices belonging to class III, and for medical devices belonging to class IIa and IIb on a representative basis, the design of the medical device and its compliance with the Essential Requirements must be examined by a Notified Body.

In the case of devices falling within Class I low risk , other than devices which are custom-made or intended for clinical investigations, the manufacturer performs the conformity assessment and documents the assessment in his own right.

In this case, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on the market. In the case of devices falling within Class IIa medium risk , other than devices which are custom-made or intended for clinical investigations, the manufacturer performs the conformity assessment and documents the assessment in his own right.

And, in order to affix the CE marking, shall follow the procedure relating to the EC declaration of conformity set out in Annex VII, coupled with either:. Instead of applying these procedures, the manufacturer may also follow the procedure relating to the EC declaration of conformity set out in Annex II full quality assurance.

In the case of devices falling within Class IIb medium risk , other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:. In the case of devices falling within Class III high risk , other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:. List of European harmonized standards that pertain to the Medical Devices Directive:.

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