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Implementing the EU Medical Devices Directive 93/42/EEC Stage 7: Ensure your devices comply with the 'Essential Requirements' You must demonstrate to your Notified Body that your product is both safe and achieves its intended purpose. As such, you must demonstrate that your devices meet Annex I of the Directive - "Essential Requirements" Whilst this Annex gives general details of the areas for consideration, no specific standards or test requirements are referred to. However, the Directive does indicate that where appropriate harmonised standards are used to demonstrate compliance with aspects of the Directive, then these standards should be considered acceptable by the Notified Body.In principle your Notified Body will question whether appropriate standards have been employed and whether the data used, to demonstrate product conformity to those standards, has been generated by an acceptable source. Independent testing is not always required. Neither must testing always be carried out to harmonised standards (although this is generally recommended). It is up to the manufacturer to demonstrate and convince his Notified Body that the risk analysis he has undertaken and the methodology employed is satisfactory to ensure that the devices meet the Essential Requirements. Reference may be made to historical use of devices, historical use of similar competitor devices and/or materials, in-house test results, or test results to non-European Standards. Your Notified Body will decide the acceptability of such information on a case by case basis.
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