MDR法规下最新的MDCG指南清单（截至2020年5月）

RA小编辑

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 documentsMDCG work in progress

Ongoing guidance documents

UDI[td]

Reference	Title	Publication
MDCG 2018-1 v3	Guidance on basic UDI-DI and changes to UDI-DI	March 2020
MDCG 2019-1	MDCG guiding principles for issuing entities rules on basic UDI-DI	January 2019
MDCG 2019-2	Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017	February 2019
MDCG 2018-2	Future EU medical device nomenclature - Description of requirements	March 2018
MDCG 2018-3	Guidance on UDI for systems and procedure packs	October 2018
MDCG 2018-4	Definitions/descriptions and formats of the UDI core elements for systems or procedure packs	October 2018
MDCG 2018-5	UDI assignment to medical device software	October 2018
MDCG 2018-6	Clarifications of UDI related responsibilities in relation to article 16	October 2018
MDCG 2018-7	Provisional considerations regarding language issues associated with the UDI database	October 2018

EUDAMED[td]

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

European Medical Device Nomenclature (EMDN)[td]

Title	Publication
The EMDN – The nomenclature of use in EUDAMED	January 2020
The CND nomenclature – Background and general principles	January 2020

Notified bodies[td]

Reference	Title	Publication
MDCG 2020-4	Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions	April 2020
MDCG 2020-3	Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD	March 2020
MDCG 2019-14	Explanatory note on MDR codes	December 2019
MDCG 2019-13	Guidance on sampling of devices for the assessment of the technical documentation	December 2019
MDCG 2019-12	Designating authority's final assessment form: Key information (EN)	October 2019
MDCG 2019-10	Application of transitional provisions concerning validity of certificates issued in accordance to the directives	October 2019
MDCG 2019-6 v2	Questions and answers: Requirements relating to notified bodies	Ocotober2019
MDCG 2018-8	Guidance on content of the certificates, voluntary certificate transfers	November 2018
NBOG BPG 2017-1	Best practice guidance on designation and notification of conformity assessment bodies	February 2018
NBOG BPG 2017-2	Best practice guidance on the information required for personnel involved in conformity assessment	February 2018
NBOG F 2017-1	Application 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 2017-2	Application 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 2017-3	Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)	February 2018
NBOG F 2017-4	Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)	February 2018
NBOG F 2017-5	Preliminary assessment review template (MDR)	February 2018
NBOG F 2017-6	Preliminary assessment review template (IVDR)	February 2018
NBOG F 2017-7	Review of qualification for the authorisation of personnel (MDR)	February 2018
NBOG F 2017-8	Review of qualification for the authorisation of personnel (IVDR)	February 2018

Clinical investigation and evaluation[td]

Reference	Title	Publication
MDCG 2020-10/1 MDCG 2020-10/2	Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form	May 2020 May 2020
MDCG 2020-8	Guidance on PMCF evaluation report template	April 2020
MDCG 2020-7	Guidance on PMCF plan template	April 2020
MDCG 2020-6	Guidance on sufficient clinical evidence for legacy devices	April 2020
MDCG 2020-5	Guidance on clinical evaluation – Equivalence	April 2020
MDCG 2019-9	Summary of safety and clinical performance	August 2019

New technologies[td]

Reference	Title	Publication
MDCG 2020-1	Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software	March 2020
MDCG 2019-11	Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746	October 2019
MDCG 2019-16	Guidance on cybersecurity for medical devices	December 2019

Other topics[td]

Reference	Title	Publication
MDCG 2020-9	Regulatory requirements for ventilators and related accessories	April 2020
MDCG 2019-3 rev.1	Interpretation of article 54(2)b	April 2020
MDCG 2020-2	Class I transitional provisions under Article 120 (3 and 4) – (MDR)	March 2020
MDCG 2019-8 v2	Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices	March 2020
MDCG 2019-15	Guidance notes for manufacturers of class I medical devices	December 2019
MDCG 2019-7	Guidance 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 guidelines	Guidelines 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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