医疗器械 欧盟技术文档清单 MDD CE Checklist.pdfVIP

MDDTechnicalFileChecklist

（EnglishVerison）

ContentsNotesY/N

PartA

Name,PostalAddressofManufacturer/EU

1

Representive

Alistingofallmanufacturingsitescoveredbythe

2

qualitysystem

3Productdescription

Productname,classificationofthedeviceand

3.1

accessories

3.2Listofaccessories(ifapplicable)

3.3Specification,modelandarticlenumbers

3.4Chosenconformityassessmentpath

3.5Intendeduse

3.6Integralpartsofthesalesunit

Abriefproducthistory(includingexistingregulatory

3.7

approvals)

4ListofharmonizedstandardsSatisfytheAnnexI

thesolutionsadoptedtosatisfytheEssentialRequirements

5EssentialRequirementschecklist

(template,Englishversion)

Overallmanufacturingandinspectionplanofthe

6

product

ENISO14971:2007

7Riskanalysis

(template,Englishversion)

8ClinicalreportDetailedseeinPartB

9Labelling,inl.Productlabelsandpackagelabels(Englishversion)

Instructionforuse,patientinformation,advertising(Englishversion)

10

material

11Declarationofconformity(template,Englishversion)

PartB

12Informationconcerningthequalitysystemspecificto

theproduct

13Detaileddescriptionsoftheproduct

1