mdcg_2021-6_en 修订版 1 法规 （EU） 2017745 – 有关临床研究的问题和答案.pdf

MedicalDevices

MedicalDeviceCoordinationGroupDocumentMDCG2021-6Rev.1

MDCG2021-6Rev.1

Regulation(EU)2017/745–QuestionsAnswers

regardingclinicalinvestigation

December2023

ThisdocumenthasbeenendorsedbytheMedicalDeviceCoordinationGroup(MDCG)

establishedbyArticle103ofRegulation(EU)2017/745.TheMDCGiscomposedof

representativesofallMemberStatesanditischairedbyarepresentativeofthe

EuropeanCommission.

ThedocumentisnotaEuropeanCommissiondocumentanditcannotberegardedas

reflectingtheofficialpositionoftheEuropeanCommission.Anyviewsexpressedin

thisdocumentarenotlegallybindingandonlytheCourtofJusticeoftheEuropean

UnioncangivebindinginterpretationsofUnionlaw.

1

MedicalDevices

MedicalDeviceCoordinationGroupDocumentMDCG2021-6Rev.1

MDCG2021-6Rev1changes

NewquestionsandanswersQ2,Q4,Q5,Q14,Q15,Q16,Q17,Q18,Q25,Q26,

Q27,Q28,Q39,Q41,Q43,Q44,Q48,Q49,Q50,

UpdatedanswersQ7(formerQ4)

Q9(formerQ6)

Q11(formerQ7)

Q12(formerQ8)

Q21(formerQ11)

Q24(formerQ14)

Q30(formerQ15)

Q32(formerQ17)+Qmodified

Q34(formerQ19)

Q35(formerQ20)

Q36(formerQ21)

UpdatedquestionsQ40(formerQ24)

Q45(formerQ26)

AnnexesAnnexI–legendupdated

AnnexII–editsforalignmentwi