European Commission (EC), MDCG, and EUDAMED Updates

European Commission MDR and IVDR EUDAMED Updates

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EUDAMED

October 2023 EUDAMED Timelines View

MDCG Publications

2024

MDCG 2024-2 Procedures for the updates of the European Medical Device Nomenclature.
February 2024 Download

MDCG 2024-1 Guidance on the vigilance system for CE-marked devices.
January 2024 Download

MDCG 2024-1-1 DSVG 01 on Cardiac ablation
January 2024 Download

MDCG 2024-1-2 Guidance on the vigilance system for CE-marked devices.
January 2024 Download

MDCG 2024-1-3 Guidance on the vigilance system for CE-marked devices.
January 2024 Download

MDCG 2024-1-4 Guidance on the vigilance system for CE-marked devices.
January 2024 Download

2023

MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence.
December 2023 Download

MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
December 2023 Download

MDCG 2019-07 Rev.1 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).
December 2023 Download

MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies.
December 2023 Download

MDCG 2023-5 Guidance on qualification and classification of Annex XVI products A guide for manufacturers and notified bodies
December 2023 Download

MDCG 2021-6 Rev. 1 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation.
December 2023 Download

MDCG 2022-11 Rev.1 MDCG Position Paper – Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements.
November 2023 Download

MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components
October 2023 Download

UDI for contact lenses Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses
October 2023 Download

Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR
September 2023 Download

Extension Q&A Rev.1 on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
July 2023 Download

MDCG 2020-3 Rev.1 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
May 2023 Download

2023/C 163/06 Commission Guidance on the content and structure of the summary of the clinical investigation report (Text with EEA relevance) 2023/C 163/06
May 2023 Download

Extension Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
March 2023 Download

MDCG 2023-3 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
February 2023 Download

MDCG 2020-16 Rev. 2 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
February 2023 Download

MDCG 2023-01 Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
January 2023 Download

MDCG 2023-02 List of Standard Fees
January 2023 Download

2022

MDCG 2022-04 Rev 1 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD
December 2022 Download

MDCG 2022-21 – GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR) ACCORDING TO REGULATION (EU) 2017/745 (MDR)
December 2022 Download

MDCG 2022-20 – Substantial modification of performance study under Regulation (EU) 2017/746
December 2022 Download

MDCG 2022-19 – Performance study application/notification documents under Regulation (EU) 2017/746
December 2022 Download

MDCG 2022-18 – MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
December 2022 Download

MDCG 2022-17 – MDCG position paper on ‘hybrid audits’
December 2022 Download

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 Download

MDCG UPDATE MDCG 2020-10/1 Rev 1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
October 2022 Download

MDCG UPDATE MDCG 2020-10/2 Rev 1 Excel template
October 2022 Download

MDCG Publication 2019-6 Rev 4 Questions and answers: Requirements relating to notified bodies
October 2022 Download

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
September 2022 Download

MDCG 2021-22 Rev.1 (September 2022) 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 Download

MDCG 2022-14 MDCG Position Paper Transition to the MDR and IVDR Notified body capacity and availability of medical
devices and IVDs
August 2022 Download

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

MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)
July 2022 Download

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

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 on in vitro diagnostic medical devices (IVDR).
May 2022 Download

MDCG 2022-9 Summary of safety and performance template.
May 2022 Download

MDCG 2022-8 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with directive 98/79/EC
May 2022 Download

MDCG 2022-7 Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
May 2022 Download

MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
May 2022 Download

MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
April 2022 Download

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

MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD
February 2022 Download

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

MDCG 2021-21 Rev.1 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
February 2022 Download

MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
January 2022 Download

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

MDCG 2020-16 Rev.1 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
January 2022 Download

2021

MDCG 2021-28 MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation.
December 2021 Download

MDCG 2021-27  MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
December 2021 Download

MDCG 2021-26 Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
October 2021 Download

MDCG 2021-25 Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC. October 2021 Download

MDCG 2021-24 Guidance on classification of medical devices.
October 2021 Download

MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
August 2021 Download

MDCG 2021-22 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
August 2021 Download

MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices.
August 2021 Download

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

MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system.
July 2021 Download

MDCG 2021-18 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)
July 2021 Download

MDCG 2021-17
MDCG 2021-17 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
July 2021 Download

MDCG 2021-16 Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)
July 2021 Download

MDCG 2021-15 Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR)
July 2021 Download

MDCG 2021-14 Explanatory note on IVDR codes
July 2021 Download

MDCG 2021-13 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
June 2021 Download

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

MDCG 2021-11 Guidance on Implant Card – Device types.
June 2021 Download

MDCG 2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices.
June 2021 Download

MDCG 2021-9 MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers.
May 2021 Download

MDCG 2021-8 Clinical investigation application/notification documents. Also covers what to do in the absence of EUDAMED.
May 2021 Download

MDCG 2021-7 Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices
May 2021 Download

MDCG 2018-1 Rev.4 Guidance on BASIC UDI-DI and changes to UDI-DI
April 2021 Download

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

MDCG 2021-5 Guidance on standardisation for medical devices
April 2021 Download

MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
April 2021 Download

MDCG 2021 Is your software a medical device?
March 2021 Download

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

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

MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
March 2021 Download

2020

MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
December 2020 Download

MDCG 2020-17 Questions and Answers related to MDCG 2020-4:
“Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”
November 2020 Download

MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
November 2020 Download

MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States
August 2020 Download

MDCG 2020-14 Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)

August 2020 Download

MDCG 2019-15 rev.1 Guidance notes for manufacturers of Class I medical devices

July 2020 Download

MDCG 2020-2 rev.1 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)

July 2020 Download

MDCG 2019-16 rev.1 Guidance on Cybersecurity for medical devices

July 2020 Download

MDCG 2019-10 rev.1 Application of transitional provisions concerning the validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC

July 2020 Download

MDCG 2020-13 Clinical evaluation assessment report template

July 2020 Download

MDCG 2018-3 Rev.1 Guidance on UDI for systems and procedure packs

June 2020 Download

MDCG 2020-12 Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product […] as well as on devices manufactured using TSE susceptible animal tissues

June 2020 Download

MDCG 2020-11 Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation

May 2020 Download

MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745

May 2020 Download

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

May 2020 Download

MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories

May 2020 Download

MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies

April 2020 Download

MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies

April 2020 Download

MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies

April 2020 Download

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

April 2020 Download

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 Download

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 Download

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

March 2020 Download

MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
March 2020 Download

MDCG Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)

March 2020 Download

MDCG 2019-8 v2 Guidance document – Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

March 2020  Download

MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI

March 2020 Download

2019

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

September 2019 SSCP Guide

MDCG 2019-10 Certificates MDD & MDR. Application of transitional provisions concerning the validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC

October 2019  Download

MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

October 2019 Download

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

MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation(EN)
December 2019 Download

MDCG 2019-14 Explanatory note on MDR codes (EN)
December 2019 Download

MDCG 2019-15 Guidance notes for manufacturers of Class I medical devices (EN)
December 2019 Download

MDCG 2019-16 Guidance on Cybersecurity for medical devices (EN)
January 2020 Download
June 2020 Download

Manufacturer Incident Report (MIR Form)

15th May 2020

30 September 2019

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