EU MDD 93/42/EEC

EU MDD 93/42/EEC

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Council Resolution 85/C 136/01 of the May 7, 1985 defined the so-called “new approach” to technical harmonization and standards with the aim of removing barriers to trade and facilitating the free movement of goods within the European Union (EU). In the health-care domain, the effect of such a resolution had been the definition of a legal framework for medical devices that consists of three directives: (1) Council Directive 90/385/EEC on Active Implantable Medical Devices (1990) [7]; (2) Council Directive 93/42/EEC on Medical Devices (1993) [8]; and (3) Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998) [9]. Therefore, such a legal framework had been originally conceived in order to “remove barriers to trade and facilitate the free movement of medical devices.” The effort of harmonization, however, had resulted in the definition of a set of common requirements for safety, which had previously been defined separately by the Member States.

Chapter Contents:

  • 2.1 Background
  • 2.2 Content of the Directive 93/42/EEC
  • 2.3 The approval process for software as a medical device
  • 2.3.1 Qualification
  • 2.3.2 Classification
  • Software as active therapeutic medical devices
  • Software intended for diagnosis or therapy
  • IVDD and software in conjunction with in vitro diagnostic devices
  • 2.3.3 Selection of the Authorized Representative and notified body
  • 2.3.4 Implementation of a quality management system
  • 2.3.5 Documenting software as a medical device
  • 2.3.6 Auditing by the notified body
  • 2.3.7 Display of the CE marking

Inspec keywords: software standards; health care; medical computing

Other keywords: EU MDD 93/42/EEC; technical harmonization; legal framework; health-care domain; Council Directive 93/42/EEC; European Union; in vitro diagnostic medical devices; Council Directive 98/79/EC; active implantable medical devices; Council Directive 90/385/EEC; IVDMD; Council Resolution 85/C 136/01; standards

Subjects: Biology and medical computing

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