资源描述：
《MHRA-指南-独立软件》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。
1、Guidanceonmedicaldevicestand-alonesoftware(includingapps)ThefollowingguidanceisforhealthcareandmedicalsoftwaredeveloperswhoareunsureoftheregulatoryrequirementsforCEmarkingstand-alonesoftwareasamedicaldevice.IntroductionManymanufacturers,softwaredeveloper,academics,cliniciansandorganisat
2、ionsareusingsoftwareforbothhealthcareandsocialcareneeds.Thisguidanceexplainshowthistechnologyisregulated.Itcoversstand-alonesoftware(alsoknownassoftwareasamedicaldevice)butnotsoftwarethatispartofanexistingmedicaldevicebecausethisseentobepartofthedevice,egsoftwarethatcontrolsaCTscanner.K
3、eypointsandexistingguidanceStand-alonesoftwareSoftwarewhichhasamedicalpurposewhichatthetimeofitbeingplacedontothemarketisnotincorporatedintoamedicaldevice.IntendedpurposeRegulationofmedicaldevicesislimitedbytheintendedpurposeasdefinedbythemanufacturer.Thiswillincludeclaimsgiveninpromoti
4、onalmaterialsforthedevice,egbrochuresandwebpages.MedicalpurposeSoftwarethathasamedicalpurposecouldbeamedicaldevice.AmedicaldeviceisdefinedinthemedicaldeviceDirective(MDD)as:“software…intendedbythemanufacturertobeusedforhumanbeingsforthepurposeof:·diagnosis,prevention,monitoring,treatmen
5、toralleviationofdisease,·diagnosis,monitoring,treatment,alleviationoforcompensationforaninjuryorhandicap,·investigation,replacementormodificationoftheanatomyorofaphysiologicalprocess,·controlofconception….”Theotherdirectivewherethisguidanceisapplicableistheactiveimplantablemedicaldevice
6、directive.SystemsThereisnodefinitionofasysteminthedirectivebuttherearespecificrequirementsforproductsplacedonthemarketthatcombineCEmarkeddevicesandnon-CEmarkedproducts,egacombinationoflaptop(notamedicaldevice),software(amedicaldevice)andheartmonitoringhardware(anaccessory)isconsideredto
7、bea‘system’iftheseareplacedonthemarkettogether.ExistingguidanceInJanuary2012,theEuropeanCommission(EC)publishedasetofguidelinesinMEDDEV2.1/6-Guidelinesonthequalificationandclassificationofstandalonesoftwareusedinhealthcarewithintheregulatoryframeworkofmedicaldevices.Theseguidel
