This page provides a range of documents to assist stakeholders in applying:
The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR.
They are drafted in collaboration with interested parties represented in the various groups and denominated by the following format: “MDCG Year-Number-revision”.
The documents on this page are not legally binding. They present a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonised implementation of the legislation.
| Reference | Title | Publication |
|---|---|---|
| MDCG 2023-6 | Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies | December 2023 |
| MDCG 2023-5 | Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies | December 2023 |
| Q&A | Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR | September 2023 |
Background note on the use of the Manual on borderline and classification for medical devices under the Directives.
| Reference | Title | Publication |
|---|---|---|
| MDCG 2020-2 rev.1 | Class I transitional provisions under Article 120 (3 and 4) – (MDR) | March 2020 |
| MDCG 2019-15 rev.1 | Guidance notes for manufacturers of class I medical devices | December 2019 |
Guidance on the Investigator’s Brochure content
Appendix A of the MDCG 2024-5
Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices
Clinical Investigation Plan Synopsis Template
Guidance on sufficient clinical evidence for legacy devices
Background note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluation
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-21 Rev.1 | Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices | February 2022 |
| MDCG 2022-1 | Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices | January 2022 |
| 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 |
| MDCG 2021-2 | Guidance on state of the art of COVID-19 rapid antibody tests | March 2021 |
| COVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 (available in all EU languages and Arabic, Chinese, Japanese, Russian) | February 2021 | |
| Conformity assessment procedures for protective equipment | July 2020 | |
| How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context | May 2020 | |
| Guidance on regulatory requirements for medical face masks | June 2020 | |
| Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context | April 2020 | |
| Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19 | April 2020 | |
| MDCG 2020-9 | Regulatory requirements for ventilators and related accessories | April 2020 |
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-3 | Questions and Answers on Custom-Made Devices | March 2021 |
| Reference | Title | Publication |
|---|---|---|
| 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 |
| MDCG 2021-13 Rev. 1 | 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 | July 2021 |
| MDCG 2021-1 Rev. 1 | Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional | May 2021 |
| 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 |
| MDCG 2019-5 | Registration of legacy devices in EUDAMED | April 2019 |
| MDCG 2019-4 | Timelines for registration of device data elements in EUDAMED | April 2019 |
| Reference | Title | Publication |
|---|---|---|
| MDCG 2024-2 | Procedures for the updates of the EMDN | February 2024 |
| MDCG 2021-12 | FAQ on the European Medical Device Nomenclature (EMDN) | June 2021 |
| The EMDN – The nomenclature of use in EUDAMED | January 2020 | |
| The CND nomenclature – Background and general principles | January 2020 | |
| MDCG 2018-2 | Future EU medical device nomenclature - Description of requirements | March 2018 |
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-11 | Guidance on Implant Card – Device types | May 2021 |
| MDCG 2019-8 v2 | Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices | March 2020 |
| Reference | Title | Publication |
|---|---|---|
| MDCG 2023-1 | Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | January 2023 |
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-27 - Rev.1 | Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | December 2023 |
| MDCG 2022-16 | Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | October 2022 |
| MDCG 2021-26 | Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | October 2021 |
Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
Appendix – Performance Study Summary Safety Reporting Form
| Reference | Title | Publication |
|---|---|---|
| MDCG 2023-4 | Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components | October 2023 |
| Infographic | Is your software a Medical Device? | March 2021 |
| MDCG 2020-1 | Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software | March 2020 |
| MDCG 2019-16 rev.1 | Guidance on cybersecurity for medical devices | December 2019 |
| MDCG 2019-11 | Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | October 2019 |
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
Note to the reader: Due to technical issues, please disregard the document displayed from 7 September 2023 until 8 September 2023.
| Reference | Title | Publication |
|---|---|---|
| MDCG 2019-7 - 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 |
| Reference | Title | Publication |
|---|---|---|
| MDCG 2024-1 | Device Specific Vigilance Guidance (DSVG) Template | January 2024 |
| MDCG 2024-1-1 | DSVG 01 on Cardiac ablation | January 2024 |
| MDCG 2024-1-2 | DSVG 02 on Coronary stents | January 2024 |
| MDCG 2024-1-3 | DSVG 03 on Cardiac implantable electronic devices (CIEDs) | January 2024 |
| MDCG 2024-1-4 | DSVG 04 on Breast implants | January 2024 |
| MDCG 2024-1-5 | DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence | June 2024 |
| MDCG 2023-3 | Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices | February 2023 |
| MDCG 2022-21 | Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 | December 2022 |
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-5 Rev.1 | Guidance on standardisation for medical devices | July 2024 |
| Reference | Title | Publication |
|---|---|---|
| MDCG 2022-7 | Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) | May 2022 |
| MDCG 2021-19 | Guidance note integration of the UDI within an organisation’s quality management system | July 2021 |
| MDCG 2021-10 | The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices | June 2021 |
| MDCG 2021-09 | MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers | May 2021 |
| MDCG 2018-1 Rev. 4 | Guidance on basic UDI-DI and changes to UDI-DI | April 2021 |
| MDCG 2020-18 | MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers | December 2020 |
| MDCG 2019-2 | Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017 | February 2019 |
| MDCG 2019-1 | MDCG guiding principles for issuing entities rules on basic UDI-DI | January 2019 |
| MDCG 2018-7 | Provisional considerations regarding language issues associated with the UDI database | October 2018 |
| MDCG 2018-6 | Clarifications of UDI related responsibilities in relation to article 16 | October 2018 |
| MDCG 2018-5 | UDI assignment to medical device software | October 2018 |
| MDCG 2018-4 | Definitions/descriptions and formats of the UDI core elements for systems or procedure packs | October 2018 |
| MDCG 2018-3 Rev.1 | Guidance on UDI for systems and procedure packs | June 2020 |
| Reference | Title | Publication |
|---|---|---|
| Q&A | Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 | July 2024 |
| MDCG 2022-11 - Rev.1 | MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR requirements | November 2023 |
| Q&A Rev. 2 | Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods | July 2024 |
| MDCG 2022-18 ADD.1 | 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 - Addendum 1 | June 2023 |
| 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 |
| MDCG 2022-14 | Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs | August 2022 |
| MDCG 2021-25 | 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 |
| MDCG 2019-3 rev.1 | Clinical evaluation consultation procedure exemptions Interpretation of article 54(2)b | April 2020 |
| Reference | Title | Publication |
|---|---|---|
| MDR/IVDR Language requirements | Overview of language requirements for manufacturers of medical devices for the information and instructions that accompany a device in a specific country | January 2024 |
| European Medicines Agency (EMA) Guidance | Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) | June 2021 |
| SCHEER guidelines | Update on the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties | June 2024 |
| CAMD FAQ | CAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisions | January 2018 |