Medical devices harmonised standards

The previous chapter outlined how device classification and the use of standards provide the basis for effective regulation of medical devices, with particular focus on the application of design control standards to the development of devices. In this chapter we look at the process for evaluation and authorisation of devices, and see how the regulatory requirements vary depending on the perceived risk of the device as indicated by its classification. It will be noted that there is considerable variation between the approaches adopted in Europe and the US and that, compared to dmgs, practical harmonisation of requirements still remains to be adopted. 

Table 10.3 Harmonised standards for labelling of medical devices.

At this point it is worth mentioning how the ALARP approach to risk acceptability changes markedly when it comes to medical devices. For example. International Standard ISO 14971 [10] affords manufacturers the ability to justify risks on an ALARP basis. The European Commission Medical Device Directive (MDD) [11] cites ISO 14971 as a Harmonised Standard however the directive contains a number of Essential Requirements on risk acceptability which appear to conflict with ISO 14971. 

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. 

ISO 62366 2007 Medical devices - Application of usability engineering to medical devices [12] is a design and development standard which is harmonised with medical device compliance requirements in many territories. It is closely aligned to risk management standard ISO 14971 2012, essentially ISO 62366 explores in greater depth those hazards which arise from a product s usabifity characteristics. Whilst intended as a standard to support the manufacture of medical devices it contains a useful framework that could be utilised by manufacturers of general HIT products where the user interface is associated with a number of important safety related hazards. 

In line with its stated intent, the standard is a process standard and specifies design and risk management activities required of medical device suppliers, health organisations and other IT vendors when medical devices are connected to a generic IT network. In order to ensure harmonisation of standards, the risk management processes described in IEC80001 mirror those expected in the Medical Device Directive. 

Medical Device Directive 98/79/EC (1998) In vitro diagnostic medical devices. http //ec. europa.eu/growth/single-markel/european-standards/harmonised-standards/iv-diagnostic-medi cal-devices/index en.htm... 

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