Altayyar Saleh S
Med Devices (Auckl). 2020 Feb 13;13:49-55. doi: 10.2147/MDER.S235467. eCollection 2020.
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.
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.
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.
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.
医疗设备可以是任何类型，如器具、体外使用的试剂、器械、仪器、机器、工具、材料、软件或其他相关物品。这些设备无论是作为单一实体还是组合使用，技术人员都应按照制造商的说明用于预防、诊断、治疗、监测、缓解疾病、补偿损伤、进行研究、替换、修改或支持人体解剖结构。
采用标准是一个自愿的过程，除非监管机构将其确定为强制性标准。制造商必须证明他们生产的医疗设备符合相关的安全和性能基本原则，并且公众可以自由获取。
各种国家和国际标准（未得到监管机构认可）、行业标准、制造商制定的标准操作程序（与国际标准无关）、未被认可的标准以及最新技术在性能、材料、设计、方法、工艺或实践方面都在不断发展。
监管机构需要确保制造商是否实施了风险管理流程并符合规定的监管要求。医疗设备的安全和性能责任由制造商和监管机构共同承担。
