Which type of device does the MDD 93/42/EEC primarily regulate?

Which type of device does the MDD 93/42/EEC primarily regulate?

• A. Class I medical devices
• B. Class II medical devices
• C. Class III medical devices
• D. All medical devices

Answer: (D)

The Medical Devices Directive (MDD) 93/42/EEC was established to create a regulatory framework governing the safety and performance of medical devices within the European Union. It applies to a broad range of medical devices, classifying them based on the level of risk they present to patients and users. The directive covers all medical devices, which includes Class I, Class II, and Class III devices. Each class represents different levels of risk, with Class I being low-risk devices, Class II medium-risk, and Class III high-risk devices, each subject to varying levels of regulatory scrutiny and requirements for conformity assessment. By regulating all classes of medical devices, the MDD ensures a comprehensive approach to safety and efficacy across a diverse array of medical technologies, thus protecting public health while facilitating the market access of these devices within the EU. Therefore, the correct answer reflects the directive's purpose to encompass the entire range of medical devices rather than limiting it to a specific class.

The Medical Devices Directive (MDD) 93/42/EEC was established to create a regulatory framework governing the safety and performance of medical devices within the European Union. It applies to a broad range of medical devices, classifying them based on the level of risk they present to patients and users.

The directive covers all medical devices, which includes Class I, Class II, and Class III devices. Each class represents different levels of risk, with Class I being low-risk devices, Class II medium-risk, and Class III high-risk devices, each subject to varying levels of regulatory scrutiny and requirements for conformity assessment. By regulating all classes of medical devices, the MDD ensures a comprehensive approach to safety and efficacy across a diverse array of medical technologies, thus protecting public health while facilitating the market access of these devices within the EU.

Therefore, the correct answer reflects the directive's purpose to encompass the entire range of medical devices rather than limiting it to a specific class.