PMCF计划(MDR)上市后临床跟踪.docx

上市后临床跟踪计划（PMCF）

PMCF计划编号:：

PMCF计划日期:

PMCF计划版本:

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SectionA.Manufacturercontactdetails

Legalmanufacturername:

Address:

SRN:

Personresponsibleforregulatorycompliance:DongBin

E-mail:

Phone:

Fax:

Authorisedrepresentative(ifapplicable):

Address地址:

Contactperson:

E-mail:

Phone:

Fax:

SectionB

Productortradename:

Modelandtype:

Model

Specifications

size

Remarks

Generaldescriptionofthedevice:

Intendedpurpose:

Intendedusers：T

BasicUDI-DI:

Model

BasicUDI-DIcode

Intendedpatientpopulation:

Medicalcondition(s):

Indications:

Contraindications:Non

Warnings:

Listanddescriptionofanyvariantsand/orconfigurationscoveredbythis

plan:

Listofanyaccessoriescoveredbythisplan:

Class:ClassIIa,rule6ofMDRAnnexⅧ

Classificationrule:

Expectedlifetime：

Novelproduct：?yes?no

Novelrelatedclinicalprocedure：?yes?no

SectionC.ActivitiesundertakenrelatedtoPMCF:results

Purpose

PMCFResearchProgram

Post-marketingclinicalfollow-up(PMCF)isplannedaftertheproductisplacedonthemarket.Thepurposeofthestudyistodemonstratethesafetyandefficacyoftheproposeddevicethroughpost-marketingclinicalfollow-up.

Intendeduseandresearchquestions

Theintendeduseisdescribedasfollows:

ThePMCFstudyaimstoaddressthefollowingquestions:

Whethertherisksidentifiedinriskmanagementareacceptableinpractice;

long-termperformanceandsafetyoftheequipment;

whetherthereareemergingrisksinpractice;

Researchmethods

Personnel

Studypopulationswillbeselectedbasedonthesamecriteriaaspremarketclinicalstudies.Theselectioncriteriaareasfollows:

Registrationcriteria

Patientseligibleforthissurveyshouldmeetthefollowingrequirements;

Exclusioncriteria

Patientsshouldnotberecruitedfortestingifanyofthefollowingarepresent:Thepatientdoesnotmeettheabovecriteria;

Patientswithseverebleedingtendency;

NumberofR