Diagnostic devices, regulation

ISO 14971 has been adopted by the European Committee for Standardization as EN ISO 14971 2012 [6]. Importantly it is one of the harmonised standards which manufacturers are obliged to comply with if they wish to certify their product as a CE Marked medical device (including in vitro diagnostic devices). Similarly in the US, the 21 code of federal regulations requires risk management to be undertaken as part of design validation (820.30 (g)). ISO 14971 is a Recognised Consensus Standard which the FDA expects manufacturers to comply with to meet this requirement. 

As previously noted, medical devices are developed and marketed under strict regulatory requirements to ensure safety and efficacy. The transcutaneous nature of the minimally invasive CGM systems on the market and in development creates additional requirements on the materials, processes, packaging, and delivery of the devices. In vitro diagnostic devices are considered to be a subclass of medical devices, and a separate EU regulation (98/79EC) applies. In contrast to in vitro diagnostic devices, medical devices need, e.g., a biocompatibility assessment, and for invasive sensors also sterilization, disinfection requirements apply. As such, the materials used in the constmction of the transcutaneous part of the sensor, and the complete sensor itself, must be biocompatible in the sense that the sensor exhibits no toxicity toward the surrounding tissue. 

Device Legislation. Regulations covering medical devices define reagents used in in vitro diagnostic tests as devices (see Medical diagnostic reagents Prosthetic and biot dicaldevices). 

Polymers and Coatings Advances ia polymer chemistry have resulted ia many successful medical devices, including diagnostic assays (26). Polymers (qv), which can be manufactured ia a wide range of compositions, ate used to enhance speed, sensitivity, and versatiUty of both biosensors and dry chemistry systems to measure vital analytes. Their properties can be regulated by composition variations and modifications. Furthermore, polymers can be configured iato simple to complex shapes. 

Community-wide regulation of medical devices commenced with the introduction of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Two further base directives followed that cover all other medical devices The Medical Devices Directive 93/42/EEC and The In Vitro Diagnostics Directive 98/79/EC. All three base directives are similar in content and structure. However, it should be noted that, in addition to dealing with the particular subject matter, the Medical Devices Directive and the In Vitro Diagnostics Directive also contained amendments to the previous device directives. The Medical Devices Directive amended articles in the Active Implantable Medical Devices Directive, while the In Vitro Diagnostics Directive amended articles in the Medical Devices Directive. 

Ultrasound and X-ray equipment are examples of diagnostic medical devices. In-vitro medical devices are distinguished from other diagnostic medical devices, in that a specimen must first of all be removed from the donor. A device worn by a diabetic that continually monitors their glucose via a non-invasive method (near-infra-red energy emissions) would be just regulated as a medical device, whereas a glucosemonitoring device that used a lancet to obtain a blood sample would be an IVD. 

Current details of the regulation of medical devices and diagnostics in Australia may be obtained through the TGA website. 

FDA regulates three types of human use diagnostic and therapeutic products—pharmaceuticals, biologicals, and medical devices—each somewhat differently. It regulates drugs through CDER biologies... 

The type approval regulations also lay down rules for in-service conformity, durability of pollution-control devices, on-board diagnostic (OBD) systems, measurement of fuel consumption, and accessibility of vehicle repair and maintenance information. 

Part 800 In vitro diagnostics/medical devices Part 1270 Tissue regulations... 

CDRH—The Center for Devices and Radiological Health Responsible for regulating medial devices, kits, and diagnostic solutions. 

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