MEDDEV 2.12-1 rev.8制造商定期总结报告

Manufacturer'sPeriodicSummaryReport(PSR)

制造定期总结报告

医疗器械警戒系统(MEDDEV2.12/lrev8)1.AdministrativeinformationTowhichNCA(s)isthisreportbeingsent?DateofthisreportReferencenumberassignedbythemanufacturerReferencenumberassignedbyNCATypeofreport□Initialreport□Follow-upreportFollow-upNumbers□Finalreport2.InformationonsubmitterofthereportStatusofsubmitter□Manufacturer□AuthorisedRepresentativewithinEEA,SwitzerlandandTurkey□Others:(identifytherole):3.ManufacturerinformationNameContactnameAddressPostcodeCityPhoneFaxE-mailCountry4.AuthorisedRepresentativeinformationNameContactnameAddressPostcodeCityPhoneFaxE-mailCountry5.Submitter'sinformation(ifdifferentfromsection3or4)Submitter'snameNameContactnameAddress

DateofPSRNewincidentsTotalnumberTotalnumberTotalnumberinPostcodeCityPhoneFaxE-mailCountry6.MedicaldeviceinformationClass□AIMDActiveimplantsDIVDAnnexIIListA□MDDClassIII□IVDAnnexIIListB□MDDClasslib□IVDDevicesforself-testing□MDDClassIla□IVDGenera□MDDClassNomenclaturesystem(preferableGMDN)NomenclaturecodeNomenclaturetextNotifiedBody(NB)ID-NumberModelnumber(s)orFamilyNameCataloguenumber(s)7.PSRinformationPSRType:□IncidentsdescribedinaFieldSafetyNoticeIfIncidentsdescribedinaFieldSafetyNotice.ManufacturersreferencenumberforFSN/FSCA□CommonandwelldocumentedincidentsStageofPSRreportingbasedon:□ObservedFailuremode□RootcauseNatureofproblemagreedforPSRreportingSummaryperiodagreed:□Everymonth□Every2months□Every3months□Every6months□Every12monthsThefiquresinthetablebelowrelateto:□EEA+CH+TR□AllPSRrecipientsNCA'sidentifiedinSection1□SingleMemberStatePleasename:-thisperiodincidentsviaPSRresolvedprogress8.Manufacturer'scomments/investigationresultsInvestigationupdateforthisperiodInitialcorrectiveactions/preventiveactionsimplementedbythemanufacturerRecommendedactionsforthisperiodifanyExpecteddateofnextPSRreport9.Distribution

ThemedicaldevicehasbeendistributedtothefollowingCountriesWithinEEA,SwitzerlandandTurkey:□ATOBEOBG□CHOCY□CZ□DE□DKQEE□ES□FI□FROGBOGR□HU□ATOBEOBG□CHOCY□CZ□DE□DKQEE□ES□FI□FROGBOGR□HU□FI□FROGBOGR□HU□IEnis□IT□LIOLT□LU□FI□FROGBOGR□HU□IEnis□IT□LIOLT□LU口LV口MT□LU口LV□LU口LV口MT□NL□NO□PLOPTORO□SEOSI□SK□TRCandidateCountries:□HR□AllEEA,CandidateCountries,SwitzerlandandTurkeyOthers:12.CommentsSubmissionofthisreportdoesnot,initselfrepresentaconclusionbythemanufacturerand/orauthorizedrepresentativeortheNationalCompetentauthoritythatthecontentofthisreportiscompleteoraccurate,thatthemedicaldevice(s)listedfailedinanymannerand/orthatthemedicaldevice(s)causedorcontributedtotheallegeddeathordeterio