NORMATIVA EUROPEA RELATIVA AI DISPOSITIVI MEDICI

Translated title of the contribution: European regulations for medical devices

L. Savarino, G. Ciapetti, D. Granchi, A. Pizzoferrato

Research output: Contribution to journalArticlepeer-review

Abstract

The employment in clinical practice and prosthetic surgery of a number of medical devices implies a great responsibility to the operators so as to make the knowledge of existing regulations mandatory. The authors illustrate the problems concerning the free circulation of medical devices within the European market. They describe the new strategy of EEC which led to the definition of the directives which apply to all medical devices and of the harmonized standards for inspecting their biological effects. The appointment of certification bodies and the accreditation of Testing Laboratories are described. Finally, particular attention is given to product certification, which is compulsory for the pre-market approval of medical devices.

Translated title of the contributionEuropean regulations for medical devices
Original languageItalian
Pages (from-to)481-493
Number of pages13
JournalMinerva Medica
Volume86
Issue number11
Publication statusPublished - 1995

ASJC Scopus subject areas

  • Medicine(all)

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