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The main Directive 93/42/EEC covers the sales and marketing of Medical Devices. This Directive has had several amendments the most recent being Directive 2007/47/EC which came fully into force on 21 March 2010.
In this latest Directive, a "Medical Device" is defined as:
"any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
and which does not achieve its principle 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."
Examples of Medical Devices are as follows:
Software can be incorporated in medical devices or exist as standalone software, for example:
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In Europe a much tougher new regulatory frameworkwill be introduced requiring some devices to go through a pre-market assessment process by the European Medicines Agency (EMA). Key changes are:
Adoption of these Regulations is expected in 2015 with full implementation by 2018.
Medical Devices are subject to the general controls of the Federal Food Drug & Cosmetic Act which are contained in the final procedural regulations in Title 21 Code of Federal Regulations Part 800-1200 (21 CFR Parts 800-1299). Unless exempt, the US FDA will classify the device. Classification identifies the level of regulatory control that is necessary to assure the safety and effectiveness of a medical device. It will also identify the marketing process (either premarket notification [510(k)] or premarket approval (PMA)) the manufacturer must complete in order to obtain US FDA clearance/approval for marketing.
To obtain US FDA clearance to market, a company must obtain the required data and information to submit a marketing application. Clinical performance data is needed for some 510(k) submissions and for most PMA applications and trials must be conducted in accordance with the US FDA’s Investigational Device Exemption (IDE) regulation in addition to marketing clearance.
Other requirements include:
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