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) »

Qarad informs its customers about the most important Regulatory updates!

Receive document updates and other regulatory news immediately in your mailbox.

Subscribe to our newsletter!

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) »

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) »

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) »

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

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 2020-16 Guidance on Classification Rules for IVD under Regulation (EU) 2017/746 November 2020 Download (405 KB) »

COVID-19

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

IVD

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

Custom Made Devices

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

Library

MDCG guidance documents

UDI

Newsletter

EUDAMED

Notified Bodies

Clinical investigation and evaluation

New technologies

Other

COVID-19

IVD

Custom Made Devices

QARAD BV

Quicklinks

Library

MDCG guidance documents

UDI

Newsletter

EUDAMED

Notified Bodies

Clinical investigation and evaluation

New technologies

Other

COVID-19

IVD

Custom Made Devices

QARAD BV

Quicklinks

Inloggen

Paswoord vergeten