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MDCG guidance documents

Consult the guidance documents of the Medical Device Cooperation group.

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Subjects

UDI

MDCG 2018-1 Guidance on BASIC UDI-DI and changes to UDI-DI

v.3 – March 2020

MDCG 2018-2 Future EU medical device nomenclature

March 2018

MDCG 2018-3 Guidance on UDI for systems and procedure packs

June 2020

MDCG 2018-4 UDI database: Def./descr. and formats of UDI core elements for systems or procedure pack

October 2018

MDCG 2018-5 UDI Assignment to Medical Device Software

October 2018

MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Art. 16 of MDR/IVDR

October 2018

MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database

October 2018

MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI

January 2019

MDCG 2019-2 Guidance on application UDI rules to device-part of products of Art.1(8), 1(9) & 1(10)

February 2019

MDCG 2021-10 – The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for MD

May 2021

MDCG 2021-19 Guidance integration UDI within organisation QMS

July 2021

MDCG 2022-7 Q&A on UDI system under MDR and IVDR

May 2022

EUDAMED

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

MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and SRN

August 2020

MDCG 2021-1 administrative practices & alternative technical solutions until EUDAMED is functional

February 2021

MDCG 2021-13 rev.1 Q&A on obligations & related rules for registration of actors of IVDR/MDR

July 2021

Notified Bodies

MDCG 2018-8 Guidance on content of the certificates, voluntary certificate transfers

November 2018

MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies

v.2 – October 2019

MDCG 2019-10 Application of transitional provisions for validity of certificate issued under (AI)MDD

July 2020 – Rev. 1

MDCG 2019-12 Designating authority’s final assessment form: Key Information (EN)

October 2019

MDCG 2019-13 Guidance on sampling of MDR Class IIa/IIb and IVDR Class B/C devices for TD assessment

December 2019

MDCG 2019-14 Explanatory note on MDR codes

December 2019

MDCG 2020-3 Guidance on sign. changes regarding MDR devices with (AI)MDD certificate (transition)

March 2020

MDCG 2020-4 Guidance on temporary measures for Notified Body audits during COVID19

April 2020

MDCG 2020-11 Guidance on the renewal of designation and monitoring of Notified Bodies under (AI)MDD

May 2020

MDCG 2020-12 on devices incorporating a medicinal product or using TSE susceptible animal tissues

June 2020

MDCG 2020-14 Guidance for NBs on use of MDSAP audit reports in surveillance audits under MDR/IVDR

August 2020

MDCG 2021-14 Explanatory note on IVDR codes

July 2021

MDCG 2021-15 Application form to be submitted by a CAB when applying for designation as NB (MDR)

July 2021

MDCG 2021-16 Application form to be submitted by a CAB when applying for designation as NB (IVDR)

July 2021

MDCG 2021-17 Applied-for scope of designation and notification of a CAB MDR

July 2021

MDCG 2021-18 Applied-for scope of designation and notification of a CAB IVDR

July 2021

MDCG 2021-23 Guidance on Article 16(4) of IVDR and MDR

August 2021

MDCG 2019-6 Rev3 QA requirements for notified bodies

October 2021

MDCG 2022-4 Guidance on appropriate surveillance for transitional provisions under Art 120 of MDR

February 2022

MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies

August 2022

MDCG 2022-15 – Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD

October 2022

MDCG 2019-6 Rev 4 – Questions and answers: Requirements relating to notified bodies

October 2022

Clinical investigation and evaluation

MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies

Rev.1 – March 2022

MDCG 2020-5 Clinical Evaluation – Equivalence A guide for manufacturers and notified bodies

April 2020

MDCG 2020-6 MDR Clinical evidence needed for medical devices previously CE marked under MDD & AIMDD

April 2020

MDCG 2020-7 PMCF Plan Template – A guide for manufacturers and notified bodies

April 2020

MDCG 2020-8 PMCF Evaluation Report Template – A guide for manufacturers and notified bodies

April 2020

MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the MDR 2017/745

May 2020

MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0

MDCG 2020-13 Clinical evaluation assessment report template

July 2020

MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation

April 2021

MDCG 2021-8 Annex I Clinical investigation – application form under MDR

Application form v1.0

MDCG 2021-8 Annex II Additional investigational device(s)

MDCG 2021-8 Annex III Additional investigational device(s)

MDCG 2021-8 Annex IV Additional investigation site(s)

MDCG 2021-8 Annex V Clinical investigation supporting documents – Appendix of documents to attach

MDCG 2021-8 Annex VI Checklist of GSPR, Standards, CS and Scientific Advice

MDCG 2021-8 Clinical investigation application-notification documents

MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations

July 2021

MDCG 2021-28 Substantial modification of clinical investigation under MDR

December 2021

MDCG 2021-28 Substantial modification of clinical investigation under MDR – Annex I

December 2021

New Technologies

MDCG 2019-11 Guidance on Qualification and Classification of Software in MDR/IVDR

October 2019

MDCG 2019-16 Guidance on Cybersecurity for medical devices

July 2020 – Rev. 1

MDCG 2020-1 Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of MD software

March

COVID-19

MDCG 2021-2 Guidance on state of the art of COVID-19 rapid antibody tests

March 2021

MDCG 2021-7 Notice to manufacturers and EC-REPs on the impact of genetic variants of SARS-COV-2 IVD

May 2021

MDCG 2021-21 Rev.1 Guidance on performance evaluation of SARS-CoV-2 IVDs

Revision 1 – February 2022

MDCG 2022-1 Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices

January 2022

IVD

MDCG 2021-4 Application of transitional provisions for certification of class D IVD according IVDR

April 2021

MDCG 2021-22 Clarification on “first certification for that type of device” under IVDR

August 2021

MDCG 2020-16 Rev. 1 Guidance on Classification Rules for IVD under Regulation (EU) 2017/746

January 2022

MDCG 2022-2 Guidance on general principles of clinical evidence for IVDs

January 2022

MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies

February 2022

MDCG 2022-6 – Guidance on significant changes regarding the transitional provision under IVDR

May 2022

MDCG 2022-8 IVDR application to legacy and old devices

May 2022

MDCG 2022-9 – Summary of safety and performance template

May 2022

MDCG 2022-10 – Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746

May 2022

MDCG 2021-22 Rev. 1 – Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746

September 2022

Custom Made Devices

MDCG 2021-3 Questions and Answers on Custom-Made Devices

March 2021

Standards

MDCG 2021-5 Guidance on standardisation for medical devices

April 2021

Implant cards

MDCG 2021-11 Guidance on Implant Card – ‘Device types’

May 2021

Other

MDCG 2019-3 Interpretation of Article 54(2)b

Rev.1 – April 2020

MDCG 2019-7 Guidance on Art. 15 of MDR/IVDR on Person Responsible for Regulatory Compliance (PRRC)

June 2019

MDCG 2019-8 v2 Guidance document Implant Card relating to the application of Art. 18 of MDR

v.2 – March 2020

MDCG 2019-15 Guidance notes for manufacturers of Class I Medical Devices

July 2020 – rev. 1

MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)

July 2020 – Rev. 1

MDCG 2020-9 Regulatory requirements for ventilators and related accessories

April 2020

MDCG 2021-25 Application of MDR requirements to ‘legacy devices’ and to devices placed on the market

October 2021

MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of MDR and IVDR

October 2021

MDCG 2021-27 Q&A on Articles 13 & 14 of MDR and IVDR

December 2021

MDCG 2022-11 – MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements

June 2022

MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional

July 2022

MDCG 2022-14 – Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs

August 2022

MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

October 2022

European Medical Device Nomenclature (EMDN)

MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN)

May 2021

Borderline and Classification

MDCG 2021-24 Guidance on classification of medical devices

October 2021

MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under MDR

April 2022

New manual on borderline and Classification in the Community Regulatory Framework for Medical Devices

September 2022

Don’t hesitate to contact us if you need help with the interpretation with one of these documents!

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Subjects

UDI

EUDAMED

Notified Bodies

Clinical investigation and evaluation

New Technologies

COVID-19

IVD

Custom Made Devices

Standards

Implant cards

Other

European Medical Device Nomenclature (EMDN)

Borderline and Classification

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