The Essential Principles of Safety and Effectiveness for Medical Devices and the Role of Standards

摘要

Purpose: A medical device may be of any type such as appliance, in vitro usable reagents, apparatus, instrument, machine, implement, material, software or other related articles. Either as a single entity or in combination, these devices are used by the skilled persons as per the manufacturer’s instructions to prevent, diagnose, treat, monitor, alleviate the disease, compensate for an injury, investigate, replace, modify or support the anatomy in human beings. Methods: Using standards is a voluntary process unless and until it is identified as a mandatory one by the regulatory authority. The manufacturers must demonstrate that the medical devices they manufacture meet the relevant Essential Principles of Safety and Performance and are freely accessible to public. Results: Various national and international standards (not recognized by the regulatory authority), industrial standards, manufacturer-developed Standard Operating Procedures (not related to international standards), non-recognized standards, and state-of-the-art techniques are in process in terms of performance, material, design, methods, process or practices. Conclusion: The regulatory authority needs to ensure whether the manufacturer has implemented the risk management processes and met the regulatory requirements set. The responsibility towards medical devices safety and performance lies with both manufacturer and the regulatory authority.