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 October 2018 Download (343 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) »

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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) »

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 October 2019 Download (70 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) »

Clinical investigation and evaluation

MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies August 2019 Download (129 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) »

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 December 2019 Download (1,76 MB) »

MDCG 2020-1 Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of MD software March Download (969 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 December 2019 Download (190 KB) »

MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR) March 2020 Download (899 KB) »

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

Library

MDCG guidance documents

UDI

Newsletter

EUDAMED

Notified Bodies

Clinical investigation and evaluation

New technologies

Other

QARAD B.V.B.A.

Quicklinks

Library

MDCG guidance documents

UDI

Newsletter

EUDAMED

Notified Bodies

Clinical investigation and evaluation

New technologies

Other

QARAD B.V.B.A.

Quicklinks

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