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[八卦新闻] MDR法规下最新的MDCG指南清单(截至2020年5月)

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发表于 2020-5-19 11:00:21 | 显示全部楼层 |阅读模式

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本帖最后由 RA小编辑 于 2020-5-19 11:02 编辑

本文来自欧盟官方网站,4月份欧盟发布了CER和PMCF的指南,为RA和MA/CA们增添了一份“新作业”

Guidance


The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.



Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the EU.

MDCG endorsed documents
MDCG work in progress

UDI
[td]
Reference
Title
Publication
MDCG 2018-1 v3Guidance on basic UDI-DI and changes to UDI-DIMarch 2020
MDCG 2019-1MDCG guiding principles for issuing entities rules on basic UDI-DIJanuary 2019
MDCG 2019-2Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017February 2019
MDCG 2018-2Future EU medical device nomenclature - Description of requirementsMarch 2018
MDCG 2018-3Guidance on UDI for systems and procedure packsOctober 2018
MDCG 2018-4Definitions/descriptions and formats of the UDI core elements for systems or procedure packsOctober 2018
MDCG 2018-5UDI assignment to medical device softwareOctober 2018
MDCG 2018-6Clarifications of UDI related responsibilities in relation to article 16October 2018
MDCG 2018-7Provisional considerations regarding language issues associated with the UDI databaseOctober 2018

EUDAMED[td]
Reference
Title
Publication
MDCG 2019-4Timelines for registration of device data elements in EUDAMEDApril 2019
MDCG 2019-5Registration of legacy devices in EUDAMEDApril 2019

European Medical Device Nomenclature (EMDN)[td]
Title
Publication
The EMDN – The nomenclature of use in EUDAMEDJanuary 2020
The CND nomenclature – Background and general principlesJanuary 2020


Notified bodies[td]
Reference
Title
Publication
MDCG 2020-4Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictionsApril 2020
MDCG 2020-3Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDDMarch 2020
MDCG 2019-14Explanatory note on MDR codesDecember 2019
MDCG 2019-13Guidance on sampling of devices for the assessment of the technical documentationDecember 2019
MDCG 2019-12Designating authority's final assessment form: Key information (EN)October 2019
MDCG 2019-10Application of transitional provisions concerning validity of certificates issued in accordance to the directivesOctober 2019
MDCG 2019-6 v2Questions and answers: Requirements relating to notified bodiesOcotober2019
MDCG 2018-8Guidance on content of the certificates, voluntary certificate transfersNovember 2018
NBOG BPG 2017-1Best practice guidance on designation and notification of conformity assessment bodiesFebruary 2018
NBOG BPG 2017-2Best practice guidance on the information required for personnel involved in conformity assessmentFebruary 2018
NBOG F 2017-1Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR)February 2018
NBOG F 2017-2Application form to be submitted by a conformity assessment body when applying for designation as a notified body under the in vitro diagnostic devices regulation (IVDR)February 2018
NBOG F 2017-3Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)February 2018
NBOG F 2017-4Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)February 2018
NBOG F 2017-5Preliminary assessment review template (MDR)February 2018
NBOG F 2017-6Preliminary assessment review template (IVDR)February 2018
NBOG F 2017-7Review of qualification for the authorisation of personnel (MDR)February 2018
NBOG F 2017-8Review of qualification for the authorisation of personnel (IVDR)February 2018

Clinical investigation and evaluation[td]
Reference
Title
Publication
Guidance on safety reporting in clinical investigations
Appendix: Clinical investigation summary safety report form
May 2020
May 2020
MDCG 2020-8Guidance on PMCF evaluation report templateApril 2020
MDCG 2020-7Guidance on PMCF plan templateApril 2020
MDCG 2020-6Guidance on sufficient clinical evidence for legacy devicesApril 2020
MDCG 2020-5Guidance on clinical evaluation – EquivalenceApril 2020
MDCG 2019-9Summary of safety and clinical performanceAugust 2019

New technologies[td]
Reference
Title
Publication
MDCG 2020-1Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device softwareMarch 2020
MDCG 2019-11Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2019
MDCG 2019-16Guidance on cybersecurity for medical devicesDecember 2019

Other topics[td]
Reference
Title
Publication
MDCG 2020-9Regulatory requirements for ventilators and related accessoriesApril 2020
MDCG 2019-3 rev.1Interpretation of article 54(2)bApril 2020
MDCG 2020-2Class I transitional provisions under Article 120 (3 and 4) – (MDR)March 2020
MDCG 2019-8 v2Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devicesMarch 2020
MDCG 2019-15Guidance notes for manufacturers of class I medical devicesDecember 2019
MDCG 2019-7Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)June 2019

Other guidance documents[td]
Reference
Title
Publication
SCHEER guidelinesGuidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices
covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties
June 2019











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