Library

MDCG guidance documents

Consult the guidance documents of the Medical Device Cooperation group.

UDI

MDCG 2018-1 Guidance on BASIC UDI-DI and changes to UDI-DI v.3 - March 2020 Download (71 KB) »

MDCG 2018-2 Future EU medical device nomenclature March 2018 Download (223 KB) »

MDCG 2018-3 Guidance on UDI for systems and procedure packs June 2020 Download (73 KB) »

MDCG 2018-4 UDI database: Def./descr. and formats of UDI core elements for systems or procedure pack October 2018 Download (300 KB) »

MDCG 2018-5 UDI Assignment to Medical Device Software October 2018 Download (344 KB) »

MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Art. 16 of MDR/IVDR October 2018 Download (298 KB) »

MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database October 2018 Download (333 KB) »

MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI January 2019 Download (215 KB) »

MDCG 2019-2 Guidance on application UDI rules to device-part of products of Art.1(8), 1(9) & 1(10) February 2019 Download (389 KB) »

MDCG 2021-10 - The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for MD May 2021 Download (417 KB) »

MDCG 2021-19 Guidance integration UDI within organisation QMS July 2021 Download (612 KB) »

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EUDAMED

MDCG 2019-4 Timelines for registration of device data elements in EUDAMED April 2019 Download (274 KB) »

MDCG 2019-5 Registration of legacy devices in EUDAMED April 2019 Download (305 KB) »

MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and SRN August 2020 Download (89 KB) »

MDCG 2021-1 administrative practices & alternative technical solutions until EUDAMED is functional February 2021 Download (610 KB) »

MDCG 2021-13 rev.1 Q&A on obligations & related rules for registration of actors of IVDR/MDR July 2021 Download (580 KB) »

Notified Bodies

MDCG 2018-8 Guidance on content of the certificates, voluntary certificate transfers November 2018 Download (205 KB) »

MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies v.2 - October 2019 Download (131 KB) »

MDCG 2019-10 Application of transitional provisions for validity of certificate issued under (AI)MDD July 2020 - Rev. 1 Download (390 KB) »

MDCG 2019-12 Designating authority's final assessment form: Key Information (EN) October 2019 Download (112 KB) »

MDCG 2019-13 Guidance on sampling of MDR Class IIa/IIb and IVDR Class B/C devices for TD assessment December 2019 Download (398 KB) »

MDCG 2019-14 Explanatory note on MDR codes December 2019 Download (181 KB) »

MDCG 2020-3 Guidance on sign. changes regarding MDR devices with (AI)MDD certificate (transition) March 2020 Download (1,03 MB) »

MDCG 2020-4 Guidance on temporary measures for Notified Body audits during COVID19 April 2020 Download (358 KB) »

MDCG 2020-11 Guidance on the renewal of designation and monitoring of Notified Bodies under (AI)MDD May 2020 Download (473 KB) »

MDCG 2020-12 on devices incorporating a medicinal product or using TSE susceptible animal tissues June 2020 Download (96 KB) »

MDCG 2020-14 Guidance for NBs on use of MDSAP audit reports in surveillance audits under MDR/IVDR August 2020 Download (89 KB) »

MDCG 2021-14 Explanatory note on IVDR codes July 2021 Download (655 KB) »

MDCG 2021-15 Application form to be submitted by a CAB when applying for designation as NB (MDR) July 2021 Download (63 KB) »

MDCG 2021-16 Application form to be submitted by a CAB when applying for designation as NB (IVDR) July 2021 Download (63 KB) »

MDCG 2021-17 Applied-for scope of designation and notification of a CAB MDR July 2021 Download (45 KB) »

MDCG 2021-18 Applied-for scope of designation and notification of a CAB IVDR July 2021 Download (52 KB) »

MDCG 2021-23 Guidance on Article 16(4) of IVDR and MDR August 2021 Download (640 KB) »

MDCG 2019-6 Rev3 QA requirements for notified bodies October 2021 Download (744 KB) »

MDCG 2022-4 Guidance on appropriate surveillance for transitional provisions under Art 120 of MDR February 2022 Download (204 KB) »

Clinical investigation and evaluation

MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies Rev.1 - March 2022 Download (637 KB) »

MDCG 2020-5 Clinical Evaluation - Equivalence A guide for manufacturers and notified bodies April 2020 Download (1,10 MB) »

MDCG 2020-6 MDR Clinical evidence needed for medical devices previously CE marked under MDD & AIMDD April 2020 Download (861 KB) »

MDCG 2020-7 PMCF Plan Template - A guide for manufacturers and notified bodies April 2020 Download (706 KB) »

MDCG 2020-8 PMCF Evaluation Report Template - A guide for manufacturers and notified bodies April 2020 Download (681 KB) »

MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the MDR 2017/745 May 2020 Download (262 KB) »

MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0 Download (157 KB) »

MDCG 2020-13 Clinical evaluation assessment report template July 2020 Download (263 KB) »

MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation April 2021 Download (425 KB) »

MDCG 2021-8 Annex I Clinical investigation – application form under MDR Application form v1.0 Download (3,05 MB) »

MDCG 2021-8 Annex II Additional investigational device(s) Download (1,98 MB) »

MDCG 2021-8 Annex III Additional comparator device(s) Download (1,46 MB) »

MDCG 2021-8 Annex IV Additional investigation site(s) Download (1,43 MB) »

MDCG 2021-8 Annex V Clinical investigation supporting documents - Appendix of documents to attach Download (24 KB) »

MDCG 2021-8 Annex VI Checklist of GSPR, Standards, CS and Scientific Advice Download (67 KB) »

MDCG 2021-8 Clinical investigation application-notification documents Download (202 KB) »

MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations July 2021 Download (666 KB) »

MDCG 2021-28 Substantial modification of clinical investigation under MDR December 2021 Download (435 KB) »

MDCG 2021-28 Substantial modification of clinical investigation under MDR - Annex I December 2021 Download (391 KB) »

New technologies

MDCG 2019-11 Guidance on Qualification and Classification of Software in MDR/IVDR October 2019 Download (274 KB) »

MDCG 2019-16 Guidance on Cybersecurity for medical devices July 2020 - Rev. 1 Download (1,92 MB) »

MDCG 2020-1 Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of MD software March Download (969 KB) »

COVID-19

MDCG 2021-2 Guidance on state of the art of COVID-19 rapid antibody tests March 2021 Download (305 KB) »

MDCG 2021-7 Notice to manufacturers and EC-REPs on the impact of genetic variants of SARS-COV-2 IVD May 2021 Download (210 KB) »

MDCG 2021-21 Rev.1 Guidance on performance evaluation of SARS-CoV-2 IVDs Revision 1 – February 2022 Download (835 KB) »

MDCG 2022-1 Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices January 2022 Download (249 KB) »

IVD

MDCG 2021-4 Application of transitional provisions for certification of class D IVD according IVDR April 2021 Download (320 KB) »

MDCG 2021-22 Clarification on “first certification for that type of device” under IVDR August 2021 Download (201 KB) »

MDCG 2020-16 Rev. 1 Guidance on Classification Rules for IVD under Regulation (EU) 2017/746 January 2022 Download (553 KB) »

MDCG 2022-2 Guidance on general principles of clinical evidence for IVDs January 2022 Download (945 KB) »

MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies February 2022 Download (848 KB) »

MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under IVDR May 2022 Download (920 KB) »

Custom Made Devices

MDCG 2021-3 Questions and Answers on Custom-Made Devices March 2021 Download (312 KB) »

Standards

MDCG 2021-5 Guidance on standardisation for medical devices April 2021 Download (656 KB) »

Implant cards

MDCG 2021-11 Guidance on Implant Card – ‘Device types’ May 2021 Download (686 KB) »

European Medical Device Nomenclature (EMDN)

MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN) May 2021 Download (247 KB) »

Other

MDCG 2019-3 Interpretation of Article 54(2)b Rev.1 - April 2020 Download (538 KB) »

MDCG 2019-7 Guidance on Art. 15 of MDR/IVDR on Person Responsible for Regulatory Compliance (PRRC) June 2019 Download (81 KB) »

MDCG 2019-8 v2 Guidance document Implant Card relating to the application of Art. 18 of MDR v.2 - March 2020 Download (459 KB) »

MDCG 2019-15 Guidance notes for manufacturers of Class I Medical Devices July 2020 - rev. 1 Download (675 KB) »

MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR) July 2020 - Rev. 1 Download (687 KB) »

MDCG 2020-9 Regulatory requirements for ventilators and related accessories April 2020 Download (915 KB) »

MDCG 2021-25 Application of MDR requirements to ‘legacy devices’ and to devices placed on the market October 2021 Download (857 KB) »

MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of MDR and IVDR October 2021 Download (605 KB) »

MDCG 2021-27 Q&A on Articles 13 & 14 of MDR and IVDR December 2021 Download (796 KB) »

Borderline and Classification

MDCG 2021-24 Guidance on classification of medical devices October 2021 Download (1,52 MB) »

MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under MDR April 2022 Download (1,46 MB) »

Library

MDCG guidance documents

UDI

Newsletter

EUDAMED

Notified Bodies

Clinical investigation and evaluation

New technologies

COVID-19

IVD

Custom Made Devices

Standards

Implant cards

European Medical Device Nomenclature (EMDN)

Other

Borderline and Classification

QARAD BV

Quicklinks

Library

MDCG guidance documents

UDI

Newsletter

EUDAMED

Notified Bodies

Clinical investigation and evaluation

New technologies

COVID-19

IVD

Custom Made Devices

Standards

Implant cards

European Medical Device Nomenclature (EMDN)

Other

Borderline and Classification

QARAD BV

Quicklinks

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