Medical Devices, which are intended for diagnostic or therapeutic uses, must comply with strict safety and efficiency requirements. 

Specifically, Legislatice Decree 46/97 - in accordance with the Directive 93/42/EEC - establishes the CE marking of medical devices for placing on the market and putting into service in the European Union. 

The CE marking process involves a series of obligations for the Manufacturer and the participant of a Notified Body to determinate the risk classes. Within the scope of Directive 93/42/EC and specific authorisations issued by the European Commision, Notified Bobies may carry out all the activities necessary to verify compliance with the "essential safety requirements" of Medical Devices. 

Depending on the conformity assessment method chosen by the company, the activites may relate to: 

• Laboratory tests with reference to the harmonized standards applicable to the specific products;
• Conformity assessments of the medical device technical files;
• Evaluation and surveillance of the Company Quality Management Systems, design and manufacturing processes required by the Directive.