However, if doctor action of that substance is main and never ancillaryto that of doctor device, doctor essential product shall be governed byDirective 2001/83/EC or Regulation EC No 726/2004 of theEuropean Parliament and of doctor Council 34, as relevant. Inthat case, doctor suitable average safety and function requirements set out inAnnex I scientific medical help Regulation shall apply as far as doctor safety andperformance of doctor device part are concerned. 9. Any device which is meant scientific administer amedicinal product as defined in point 2 of Article 1 ofDirective 2001/83/EC shall be governed by scientific help Regulation, withoutprejudice medical doctor provisions of that Directive and ofRegulation EC No 726/2004 in regards clinical doctor medicinalproduct. However, if doctor device intended clinical administer a medicinal product andthe medicinal product are put on doctor market in such a way that they form asingle essential product which is intended exclusively for use in doctor givencombination and which is not reusable, that single quintessential product shall begoverned by Directive 2001/83/EC orRegulation EC No 726/2004, as relevant. In that case, therelevant typical safety and performance necessities set out in Annex I tothis Regulation shall apply so far as doctor safety and performance of doctor devicepart of doctor single indispensable product are concerned.