EC 93 442
Council Directive 93/42/EEC concerning medical devices
- Standard No.
- EC 93 442
- Release Date
- 1993
- Published By
- /
- Introduction
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Standard Name: Council Directive 93/42/EEC concerning medical devices
Standard Number: 93/42/EEC
Scope: This directive addresses the regulation of medical devices within the European Union. It aims to harmonize the laws, regulations, and administrative provisions of the Member States to ensure the safety, health protection, and performance characteristics of medical devices. The directive also seeks to eliminate trade barriers within the Community by standardizing certification and inspection procedures across Member States.
Analysis: The Council Directive 93/42/EEC, adopted on 14 June 1993, is a significant legislative act within the European Union aimed at regulating medical devices. It was established to create a unified internal market by ensuring the free movement of medical devices across Member States, while maintaining high standards of safety and health protection. The directive recognizes the existing disparities in national provisions and seeks to harmonize these to facilitate trade and protect patients and users. Amendments to the directive, such as those introduced by Directives 98/79/EC, 2000/70/EC, 2001/104/EC, Regulation (EC) No 1882/2003, and Directive 2007/47/EC, further refine and update its provisions to keep pace with advancements in medical technology and regulatory practices.
