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If the therapy does not involve drugs, does the EMA need to be contacted? Is there another relevant organization which should be contacted?
Please see here for non-pharmaceutical products: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/gen.... In general, we advise you to contact your national competent authority very early - and you might get great support from ethic committees located at your local/ regional university hospitals etc.