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The Official Journal of the European Union of 11 November 2003 published three new harmonised standards relating to medical devices. These standards cover the biological evaluation and the clinical investigation of medical devices, two crucial areas.
Clinical data are always requested to demonstrate the compliance of a medical device with the regulation. Furthermore, clinical investigations are requested for Class III devices and for implantable and long-term invasive devices falling within Class IIa or IIb.
Access the list of new standards in: English, français, nederlands CEBECAv. F. Van Kalkenlaan
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