Tests on Medical Devices | Directive 93/42/CE

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

Specifically, Legislative 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 participation of a Notified Body to determine the risk classes. Within the scope of Directive 93/42/EC and specific authorisations issued by the European Commission, Notified Bodies 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 activities may relate to:

  • Laboratory tests with reference to the harmonised standards applicable to the specific products;
  • Conformity assessments of the medical device technical files;
  • Assessments and monitoring of the Company's Quality Systems, design and manufacturing processes required by the same Directive.

In order to verify the CE conformity of the devices produced, manufacturers are required to carry out testing activities through bodies authorized by the competent Ministry and notified by the European Community considered to meet the minimum requirements set out in Directive 93/42/EC.

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