220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

111the use of resources, the resulting outcome and the quality oflife for the patients; → see also drug utilisation study.medical culture Differences in medical culture and traditions areespecially important when running multinational trials orwhen comparing their results; examples for such differences andinfluence factors: prevalence of diseases, pharmaceutical expenditures,drug utilisation and self medication (OTC, herbal products),diagnostics, nutrition etc.; → see also bias, health care services,prescription.medical device def. (EC): “any instrument, apparatus, appliance,material or other article, including software, whether used aloneor in combination, intended by the manufacturer to be used forhuman beings solely or principally for the purposes of: diagnosis,prevention, monitoring, treatment or alleviation of disease, injuryor handicap, investigation, replacement or modification ofthe anatomy or of a physiological process, control of conception,and which does not achieve its principal intended action in or onthe human body by pharmacological, immunological or metabolicmeans, but which may be assisted in its function by such means”;active m.d. means “any m.d. relying for its functioning on a sourceof electrical energy or any source of power other than that directlygenerated by the human body or gravity”; active implantable m.d.means “any active medical device which is intended to be totally orpartially introduced, surgically or medically, into the human bodyor by medical intervention into a natural orifice, and which is intendedto remain after the procedure”; depending on the level ofvulnerability, m.ds. are divided in 4 classes, class I, IIa, IIb and III(with increasing risk potential), for which different conformity andquality assessment procedures are requested; → see ce marking,device, drug delivery systems, ec type-examination, ec typeexaminationcertificate, investigational device exemption,medical device reporting.medical device reporting (MDR) Most regulations require thatmanufacturers, distributors or importers of devices reportto regulatory authorities when they become aware of informationthat one of their devices may have caused or contributedto a death or serious injury, or when a recurrent malfunction islikely to cause death or serious injury; EC: as “incidents” are considered“any malfunction or deterioration in the characteristicsand/or performance of a device, as well as any inadequacy in thelabelling or the instructions for the use” as well as “any technicalor medical reason in relation to the characteristics or performanceof a device … leading to systematic recall of devices of thesame type”; reporting of death or serious injury has to be donemed