Medical Directives
Introduction to Medical Directives
Unified European market makers to bring the convenience and opportunities. The field of medical devices, the Commission developed a three EU directives, coordinated-to-market requirements. These three commands are the Active Implantable Medical Devices Directive (AIMD, 0/335 / EEC), Medical Devices Directive (MDD 93/42/EEC) and in vitro Diagnostic Devices Directive (IVDD, 8/79 / EEC). With the end of the transitional period and the enforcement of the directive in the EU market for medical devices, must meet the related instruction requirements, and to affix the CE mark, otherwise they will be severely punished.
MDD directive applies to the widest range of implantation in addition to the active and in vitro diagnosis outside of almost all medical devices, passive medical devices (such as dressings, catheters, syringes, etc.) as well as active medical devices (such as X-ray machine anesthesia machines, monitors, etc.). June 14, 1998 MDD Directive (93/42/EEC) the termination of the transitional period, from June 15, 1998, and only with the CE marking of medical devices in order to enter the EU market.
MDD directive a total of 23 articles and 12 appendices, and instructions to the medical device market is safe. The so-called "safe" medical devices, should meet the basic requirements in Appendix I; conformity assessment according to risk types of products; meet the basic requirements and has passed the appropriate conformity assessment procedures of medical devices must carry the CE mark.
According to the product's intended use, continued use of time and is intrusive and active products, medical devices into four categories ie I, IIa, IIb and Class III products of class I sterile or measuring function of medical devices , called the Special Class I MDD directive Appendix IX 18 classification rules as guidance. The higher the category, means that the higher the level of risk, the higher the conformity assessment requirements.
In accordance with the classification of the product, the manufacturer can choose the most suitable for their requirements of conformity assessment procedures (shown below). In addition to conformity assessment procedures for without sterilization and measurement functions of Class I medical devices (MDD Appendix VII) by the manufacturer itself, all other conformity assessment procedures must be notified body. Notified Bodies are usually based on the quality system of conformity assessment procedures to review the manufacturer's quality management system, the assessment in accordance with the ISO13485 standard, of course, include the regulatory requirements of the MDD directive.
Therefore, the majority of medical device products, must be duly authorized by the European Union Notified Body to perform the certification of the product. Manufacturers are successfully notified body certification, can its products on the official logo CE mark.
Unified European market makers to bring the convenience and opportunities. The field of medical devices, the Commission developed a three EU directives, coordinated-to-market requirements. These three commands are the Active Implantable Medical Devices Directive (AIMD, 0/335 / EEC), Medical Devices Directive (MDD 93/42/EEC) and in vitro Diagnostic Devices Directive (IVDD, 8/79 / EEC). With the end of the transitional period and the enforcement of the directive in the EU market for medical devices, must meet the related instruction requirements, and to affix the CE mark, otherwise they will be severely punished.
MDD directive applies to the widest range of implantation in addition to the active and in vitro diagnosis outside of almost all medical devices, passive medical devices (such as dressings, catheters, syringes, etc.) as well as active medical devices (such as X-ray machine anesthesia machines, monitors, etc.). June 14, 1998 MDD Directive (93/42/EEC) the termination of the transitional period, from June 15, 1998, and only with the CE marking of medical devices in order to enter the EU market.
MDD directive a total of 23 articles and 12 appendices, and instructions to the medical device market is safe. The so-called "safe" medical devices, should meet the basic requirements in Appendix I; conformity assessment according to risk types of products; meet the basic requirements and has passed the appropriate conformity assessment procedures of medical devices must carry the CE mark.
According to the product's intended use, continued use of time and is intrusive and active products, medical devices into four categories ie I, IIa, IIb and Class III products of class I sterile or measuring function of medical devices , called the Special Class I MDD directive Appendix IX 18 classification rules as guidance. The higher the category, means that the higher the level of risk, the higher the conformity assessment requirements.
In accordance with the classification of the product, the manufacturer can choose the most suitable for their requirements of conformity assessment procedures (shown below). In addition to conformity assessment procedures for without sterilization and measurement functions of Class I medical devices (MDD Appendix VII) by the manufacturer itself, all other conformity assessment procedures must be notified body. Notified Bodies are usually based on the quality system of conformity assessment procedures to review the manufacturer's quality management system, the assessment in accordance with the ISO13485 standard, of course, include the regulatory requirements of the MDD directive.
Therefore, the majority of medical device products, must be duly authorized by the European Union Notified Body to perform the certification of the product. Manufacturers are successfully notified body certification, can its products on the official logo CE mark.
