A medical device is any instrument, apparatus or appliance that is used to diagnose, monitor or treat a disease, injury or handicap in humans. The term “medical device” applies to a broad range of products, devices and equipment, from simple tongue depressors and bedpans to laser surgical devices. Medical devices can also include certain electronic radiation emitting devices with medical applications, including ultrasound devices and x-ray machines.
While the term is broadly applied, medical devices should not be confused with other classes of products used to treat medical conditions. For example, medications and pharmaceutical preparations, which treat medical conditions through chemical action or by being metabolized by the body, are not considered medical devices, and are subject to different regulations and requirements.
As part of the Notified Body assessment, a manufacturer must develop technical documentation or design dossiers in order to evaluate the compliance of their device against the essential requirements and establish a quality management system that meets the requirements of the Medical Device Directive 93/42/EEC. Manufacturers must also comply with EU Regulation 722/2012 regarding the use of materials of animal origin which requires manufacturers to utilize science-based processes to eliminate or inactivate TSE-infectious agents. In addition to legislative documents, manufacturers must also consider guidance documents, consensus statements and interpretative documents under the MDD 93/42/EEC.
- By complying with the Essential Requirements of the EU’s MDD 93/42/EEC and other regulations that apply to medical devices, manufacturers can tap into the European marketplace which consists of 500 million consumers. In addition, medical devices bearing the CE mark may achieve faster regulatory review and approval in other global markets.
TÜV SÜD Product Service is the world’s largest EU Notified Body for medical devices covered by MDDs. Our extensive network makes TÜV SÜD Product Service an effective single source for manufacturers seeking expertise in the testing and certification of medical devices to EU requirements, as well as regulations applicable to these devices in other major medical device markets.
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