MDCG_2024-11 体外诊断医疗器械鉴定指南 &MDCG_2024-12_纠正和预防措施（CAPA）计划评估_合格评定机构、公告机构、指定机构和联合评估的指导

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Medical Device Coordination Group Document

applicable for☒MDR 区IVDR

MDCG 2024-12

Corrective and preventive action (CAPA)plan assessment:

guidance and templates for conformity assessment

bodies,notified bodies,designating authorities and joint

assessment teams

October 2024

This document has been endorsed by the Medical Device Coordination Group(MDCG)

established by Article 103 of Regulation(EU)2017/745.The MDCG is composed of

representatives of all Member States and it is chaired by a representative of the European

Commission.

The document is not a European Commission document and it cannot be regarded as

reflecting the official position of the European Commission.Any views expressed in this

document are not legally binding and only the Court of Justice of the European Union can

give binding interpretations of Union law.

Page2 of 11

Medical Device Coordination Group Document MDCG 2024-12

applicable for ☒MDR 区IVDR

Contents

1 Introduction ............................................................................................................................... 3

2 Scope..........................................................................................................................................3

3 Timelinesofthe process ....................................................................................................... 4

4 Considerations for the NB..................................................................................................... 4

4.1 Corrections ........................................................................................................................... 4

4.2 Root cause(s) ...................................................................................................................... 6

4.3 Corrective and preventive actions ................................................................................... 8

4.4 Actions for verification of effectiveness ........................................................................... 9

5 Considerations forthe DA ................................................................................................... 10

6 Considerations forthe JAT ................................................................................................... 11

Annex I: Template CAPA plan and assessment thereon........................................................... 1

Annex II: Template JAT review of the CAPA and the DA's opinion ....................................... 1

Medical Device Coordination Group Document MDCG 2024-12

Page 3 of 11

applicable for☒MDR 区IVDR

1 INTRODUCTION

This guidance document is intended for conformity assessment bodies(CABs),notified

bodies(NBs),designating authorities(DAs),and Joint Assessment Teams (JATs)involved

in Regulation(EU)2017/745 on medical devices(hereafter MDR)and Regulation(EU)

2017/746 on in vitro diagnostic medical devices (hereafter IVDR).It should be read in

conjunction with the guidance document MDCG 2022-13"Designation,re-assessment and

notification of conformity assessment bodies and notified bodies”1.

This document aims to provide guidance for:

- NBs²when establishing the corrective and preventive action(CAPA)plan to address

the non-compliances(NCs)resulting from joint assessments according to Article

39(5)of the MDR or Article 35(5)of the IVDR,

authorities responsible for notified bodies (hereafter,the DAs)when conducting

reviews of and providing opinions on CAPA plans of notified bodies according to

Article 39(7)of the MDR or Article 35(7)of the IVDR and

-JATs when considering the CAPA plan and the DA's opinion thereon according to

Article 39(7)of the MDR or Article 35(7)of the IVDR.

The use of the templates in Annex I (hereafter CAPA template)and Annex Il(hereafter JAT

review template)to this guidance is not mandatory.However,using them according to this

guidance to structure CAPA plans and conduct their reviews will facilitate an efficient,

consistent and timely CAPA review process for NBs,DAs and JATs.

The formal list of non-compliances from the on-site assessment provided by the DA serves

as the input to the CAPA process.When completing the CAPA template,the wording,legal

references,and classification of the NC(s)should be restated without modification.This

includes the official DG SANTE translation of the NC,if applicable and provided³.

Clear and traceable communication throughout the CAPA process is crucial to ensure an

efficient review by the JAT of CAPA plans confirmed by the DA,as well as the DA's opinion

regarding those CAPA plans,ultimately facilitating the JAT's final opinion.

2 ScOPE

This document provides guidance for CABs,NBs,DAs and JATs on using the templates in

AnnexI and Annex lduring assessments of NBs and CABs under the MDR and the IVDR.

These templates are primarily designed for re-assessments of NBs.However,they can also

be applied during assessments of CABs applying for designation as an NB,assessments

relating to extensions of an NB's scope of designation,and assessments relating to

challenges to an NB's competence under Article 47 MDR or Article 43 IVDR.While this

https://health.ec.europa.eu/medical-devices-sector/new-requlations/quidance-mdcg-endorsed-documents-and-other-

guidance en#sec14

2 Reference to NBs throughout this document may also be considered relevant to CABs.

3 MDCG 2022-13 describes the official DG SANTE translations of the NCs in the last paragraph of section 2.2.5.

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标签： #医疗器械 #指南 #预防

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Page1of11MedicalDeviceCoordinationGroupDocumentapplicablefor☒MDR区IVDRMDCG2024-12MDCG2024-12Correctiveandpreventiveaction(CAPA)planassessment:guidanceandtemplatesforconformityassessmentbodies,notifiedbodies,designatingauthoritiesandjointassessmentteamsOctober2024ThisdocumenthasbeenendorsedbytheMedica...

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