23 Jul MDCG Guidance
What is MDCG?
The MDCG ensures that regulatory authorities in the European Union member states have a forum for coordinating their efforts and sharing best practices related to medical device regulations. This includes the implementation and application of the MDR and the IVDR. This group also provides advice and assistance to the Commission, particularly in areas where harmonization and coordination of member states’ practices are needed to ensure the safety and performance of medical devices and in vitro diagnostic medical devices.
Below are listed all MDCG documents:
Annex XVI products
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| 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 | |
Borderline and Classification
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| Manual on Borderline | Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v3 | September 2023 | |
| MDCG 2022-5 | Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices | April 2022 | |
| MDCG 2021-24 | Guidance on classification of medical devices | October 2021 | |
| Helsinki Procedure | Helsinki Procedure for borderline and classification under MDR & IVDR | September 2021 |
Class I Devices
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| 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 |
Clinical Investigation and Evaluation
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| 2023/C 163/06 | Commission Guidance on the content and structure of the summary of the clinical investigation report | May 2023 | |
| MDCG 2021-28 | Substantial modification of clinical investigation under Medical Device Regulation | December 2021 | |
| MDCG 2021-20 | Instructions for generating CIV-ID for MDR Clinical Investigations | July 2021 | |
| MDCG 2021-8 | Clinical investigation application/notification documents | May 2021 | |
| MDCG 2021-6 – Rev. 1 | Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation | April 2021 | |
| MDCG 2020-13 | Clinical evaluation assessment report template | July 2020 | |
| MDCG 2020-10/1 Rev.1 | Guidance on safety reporting in clinical investigations | October 2022 | |
| MDCG 2020-10/2 Rev. 1 | Appendix: Clinical investigation summary safety report form | October 2022 | |
| MDCG 2020-8 | Guidance on PMCF evaluation report template | April 2020 | |
| MDCG 2020-7 | Guidance on PMCF plan template | April 2020 | |
| MDCG 2020-6 | Guidance on sufficient clinical evidence for legacy devices | April 2020 | |
| MDCG 2020-5 | Guidance on clinical evaluation – Equivalence | April 2020 | |
| MDCG 2019-9 – Rev.1 | Summary of safety and clinical performance | March 2022 |
Covid-19
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| 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 | |
| MDCG 2020-9 | Regulatory requirements for ventilators and related accessories | April 2020 |
Custom-Made Devices
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| MDCG 2021-3 | Questions and Answers on Custom-Made Devices | March 2021 |
EUDAMED
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| 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 |
European Medical Device Nomenclature (EMDN)
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| MDCG 2021-12 | FAQ on the European Medical Device Nomenclature (EMDN) | June 2021 | |
| MDCG 2018-2 | Future EU medical device nomenclature – Description of requirements | March 2018 | |
| European Medical Device Nomenclature (EMDN) | The nomenclature of use in EUDAMED | January 2020 | |
| CND Nomenclature | Background | January 2020 |
Implant cards
| Reference | Title | Main Topics / Summary | Publication Date | |
|---|---|---|---|---|
| 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 |
In-house devices
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| 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 |
Authorised Representatives, Importers, Distributors
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| MDCG 2022-16 | Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | October 2022 | |
| MDCG 2021-27 | Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | December 2021 | |
| MDCG 2021-26 | Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | October 2021 |
In Vitro Diagnostic medical devices (IVD)
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| MDCG 2022-20 | Substantial modification of performance study under Regulation (EU) 2017/746 | December 2022 | |
| MDCG 2022-19 | Performance study application/notification documents under Regulation (EU) 2017/746 | December 2022 | |
| 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 | |
| MDCG 2021-22 rev.1 | 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 | |
| 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 | |
| MDCG 2022-9 | Summary of safety and performance template | May 2022 | |
| 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 | |
| MDCG 2022-6 | Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR | May 2022 | |
| MDCG 2022-3 | Verification of manufactured class D IVDs by notified bodies | February 2022 | |
| MDCG 2022-2 | Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) | January 2022 | |
| 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 | |
| MDCG 2020-16 Rev.2 | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 | February 2023 |
New technologies
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| 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 |
Notified bodies
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| 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 | |
| MDCG 2023-2 MDCG 2023-2 MDR MDCG 2023-2 IVDR | List of Standard Fees | January 2023 | |
| MDCG 2022-4 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 | |
| MDCG 2022-17 | MDCG position paper on “hybrid audits” | December 2022 | |
| MDCG 2019-6 Rev.4 | Questions and answers: Requirements relating to notified bodies | October 2022 | |
| MDCG 2022-13 | Designation, re-assessment and notification of conformity assessment bodies and notified bodies | August 2022 | |
| 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 | |
| MDCG 2021-18 | Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) | July 2021 | |
| MDCG 2021-17 | Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) | July 2021 | |
| 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 | |
| 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 | |
| MDCG 2021-14 | Explanatory note on IVDR codes | July 2021 | |
| 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” | December 2020 | |
| 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 | |
| MDCG 2020-12 | Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues | June 2020 | |
| 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 (EU) 920/2013 | May 2020 | |
| 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 | |
| MDCG 2019-14 | Explanatory note on MDR codes | December 2019 | |
| MDCG 2019-13 | Guidance on sampling of devices for the assessment of the technical documentation | December 2019 | |
| MDCG 2019-12 | Designating authority’s final assessment form: Key information (EN) | October 2019 | |
| MDCG 2019-10 rev.1 | Application of transitional provisions concerning validity of certificates issued in accordance to the directives | October 2019 | |
| MDCG 2018-8 | Guidance on content of the certificates, voluntary certificate transfers | November 2018 | |
| NBOG BPG 2017-2 | Best practice guidance on the information required for personnel involved in conformity assessment | February 2018 | |
| NBOG F 2017-8 | Review of qualification for the authorisation of personnel (IVDR) | February 2018 | |
| NBOG F 2017-7 | Review of qualification for the authorisation of personnel (MDR) | February 2018 | |
| NBOG F 2017-6 | Preliminary assessment review template (IVDR) | February 2018 | |
| NBOG F 2017-5 | Preliminary assessment review template (MDR) | February 2018 |
Post-Market Surveillance and Vigilance (PMS)
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| 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 |
Standards
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| MDCG 2021-5 | Guidance on standardisation for medical devices | April 2021 |
Unique Device Identifier (UDI)
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| 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 |
Other topics
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| Q&A Rev. 1 | 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 2023 | |
| 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 2022-11 – Rev. 1 | MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements | November 2023 | |
| 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 2019-7 | 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) | June 2019 | |
| MDCG 2019-3 rev.1 | Clinical evaluation consultation procedure exemptions Interpretation of article 54(2)b | April 2020 |
Other guidance documents
| Reference | Title | Main Topics / Summary | Publication Date |
|---|---|---|---|
| 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 | 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 2019 | |
| CAMD FAQ | CAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisions | January 2018 |
Subscribe to our Newsletter to receive relevant regulatory updates related to EU.
No Comments