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At RN Electronics we can offer low cost Safety Testing and Consultation services to meet the requirements of the Medical Devices Directive (93/68/EEC).
The purpose of the directive is to outline a set of harmonised safety requirements for medical devices.
This Directive 93/68/EEC applies to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices. The directive defines a medical device as any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
Classification and need to involve notified body
As per directive 93/68/EEC Medical devices are classified as:
• Class I medical device
• Class IIa medical device
• Class IIb medical device
• Class III medical device
Class I devices are considered low risk, Class IIa and IIb are considered medium risk, and Class III devices are considered high risk. To review which category your product falls under see the medical devices guidance document.
The conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified body should be compulsory at the production stage; whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market.
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If you would like a quote, please complete and return a Safety Questionnaire or for further information contact RN Electronics an established, cost effective, knowledgeable and complete service solution.