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Each,,,,device,,,,must,,,,be,,,,accompanied,,,,by,,,,the,,,,information,,,,needed,,,,to,,,,use,,,,it,,,,safely,,,,and,,,,properly,,,,,taking,,,,account,,,,of,,,,the,,,,training,,,,and,,,,knowledge,,,,of,,,,the,,,,potential,,,,users,,,,,and,,,,to,,,,identify,,,,the,,,,manufacturer.,,,,As,,far,,as,,practicable,,and,,appropriate,,,the,,information,,needed,,to,,use,,the,,device,,safely,,must,,be,,set,,out,,on,,the,,device,,itself,,and/or,,on,,the,,packaging,,for,,each,,unit,,or,,,where,,appropriate,,,on,,the,,sales,,packaging.,,It,,must,,include,,in,,particular:.,,,,,The,,,various,,,components,,,of,,,the,,,CE,,,marking,,,must,,,have,,,substantially,,,the,,,same,,,vertical,,,dimension,,,,which,,,may,,,not,,,be,,,less,,,than,,,5,,,mm.,,,Clinical,,investigations,,must,,be,,carried,,out,,in,,accordance,,with,,the,,Helsinki,,Declaration,,adopted,,by,,the,,18th,,World,,Medical,,Assembly,,in,,Helsinki,,,Finland,,,in,,1964,,,as,,last,,amended,,by,,the,,World,,Medical,,Assembly.,,3.,,ANNEXXII,,-CE,,MARKING,,OF,,CONFORMITY.,,4.4.,,,

The,,application,,includes:.,,5.,,,At,,,,trade,,,,fairs,,,,,exhibitions,,,,,demonstrations,,,,,etc.,,,,Whereas,,,in,,,cases,,,where,,,the,,,conformity,,,of,,,the,,,devices,,,can,,,be,,,assessed,,,under,,,the,,,responsibility,,,of,,,the,,,manufacturer,,,the,,,competent,,,authorities,,,must,,,be,,,able,,,,particularly,,,in,,,emergencies,,,,to,,,contact,,,a,,,person,,,responsible,,,for,,,placing,,,the,,,device,,,on,,,the,,,market,,,and,,,established,,,in,,,the,,,Community,,,,whether,,,the,,,manufacturer,,,or,,,another,,,person,,,established,,,in,,,the,,,Community,,,and,,,designated,,,by,,,the,,,manufacturer,,,for,,,the,,,purpose;.,,,ARTICLE,,,,17,,,,-CE,,,,Marking.,,,,(i),,,any,,,malfunction,,,or,,,deterioration,,,in,,,the,,,characteristics,,,and/or,,,performance,,,of,,,a,,,device,,,,as,,,well,,,as,,,any,,,inadequacy,,,in,,,the,,,labelling,,,or,,,the,,,instructions,,,for,,,use,,,which,,,might,,,lead,,,to,,,or,,,might,,,have,,,led,,,to,,,the,,,death,,,of,,,a,,,patient,,,or,,,user,,,or,,,to,,,a,,,serious,,,deterioration,,,in,,,his,,,state,,,of,,,health;,,,(ii),,,any,,,technical,,,or,,,medical,,,reason,,,connected,,,with,,,the,,,characteristics,,,or,,,performance,,,of,,,a,,,device,,,for,,,the,,,reasons,,,referred,,,to,,,in,,,subparagraph,,,(i),,,leading,,,to,,,systematic,,,recall,,,of,,,devices,,,of,,,the,,,same,,,type,,,by,,,the,,,manufacturer.,,,All,,,,active,,,,therapeutic,,,,devices,,,,intended,,,,to,,,,administer,,,,or,,,,exchange,,,,energy,,,,are,,,,in,,,,Class,,,,IIa,,,,unless,,,,their,,,,characteristics,,,,are,,,,such,,,,that,,,,they,,,,may,,,,administer,,,,or,,,,exchange,,,,energy,,,,to,,,,or,,,,from,,,,the,,,,human,,,,body,,,,in,,,,a,,,,potentially,,,,hazardous,,,,way,,,,,taking,,,,account,,,,of,,,,the,,,,nature,,,,,the,,,,density,,,,and,,,,site,,,,of,,,,application,,,,of,,,,the,,,,energy,,,,,in,,,,which,,,,case,,,,they,,,,are,,,,in,,,,Class,,,,IIb.,,,,On,,imperative,,grounds,,of,,urgency,,,the,,Commission,,may,,use,,the,,urgency,,procedure,,referred,,to,,in,,Article,,7(4).,,ANNEX,,X,,-CLINICAL,,EVALUATION.,,The,,,,relevant,,,,essential,,,,requirements,,,,of,,,,Annex,,,,I,,,,to,,,,this,,,,Directive,,,,shall,,,,apply,,,,as,,,,far,,,,as,,,,safety,,,,and,,,,performance-related,,,,device,,,,features,,,,are,,,,concerned.,,,,

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