This table lists all the documents published by the Medical Devices Coordination Group (MDCG), and helps to know at a glance the theme, the target audience and the type of MD concerned for each document. Would you like to know more? Find the complete summary of each document by clicking on the MDCG number concerned. Enjoy reading !
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MDCG 2024
|
Number |
Version and Title | Theme | Target audience | Products concerned |
| MDCG 2024-1 | Guidance on the vigilance system for CE-marked devices – DSVG 00 Device Specific Vigilance Guidance Template | Vigilance | Manufacturers | Specific devices : cardiac ablation, coronary stents, cardiac implantable electronic devices, breast implants |
| MDCG 2024-2 | Procedures for the updates of the European Medical Device Nomenclature | European Medical Device Nomenclature (EMDN) | All the actors | MD, IVD |
| MDCG 2024-3 | Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices | Clinical investigation plan (CIP) | Sponsor of clinical investigation | MD |
MDCG 2023
|
Number |
Version and Title | Theme | Target audience | Products concerned |
| MDCG 2023-1 | Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | Dispositifs in house | Etablissements de santé, Professionnels de santé | DM, DIV |
| MDCG 2023-2 | List of standard fees | Liste de frais standards | Organismes notifiés | DM, DIV |
| MDCG 2023-3 | Questions and answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices | Vigilance | Autorités compétentes, opérateurs économiques et autres parties concernées | DM |
| MDCG 2023-4 | Medical Device Software (MDSW) –Hardware combinations | Software | Manufacturers | MDSW (Medical device software) |
| MDCG 2023-5 | Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies | Qualification and classification | Manufacturers, Notified bodies | Products without an intended purpose listed in Annex XVI |
| MDCG 2023-6 | Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies | Clinical evaluation, demonstrating equivalence | Manufacturers, Notified bodies | Products without an intended purpose listed in Annex XVI |
| 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 | Clinical investigation exemption, demonstrating equivalence | Manufacturers | Class III and implantable MD |
MDCG 2022
|
Number |
Version and Title | Theme | Target audience | Products concerned |
| MDCG 2022-1 | Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices – Janvier 2022 | Compliance of SARS-CoV-2 IVDs with the requirements of Directive 98/79/EC or Regulation (EU) 2017/746. | Manufacturers of IVDs for the detection/quantification of markers of SARS-CoV-2 infection established outside the EU or EEA and intending to place their devices on the EU market. | IVD |
| MDCG 2022-2 | Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) | Clinical evidence – Performance evaluation | Manufacturers, investigators and study sponsors, regulators, notified bodies and other stakeholders when considering clinical evidence | IVD |
| MDCG 2022-3 | Verification of manufactured class D IVDs by notified bodies | Conformity Assessment | Notified Bodies | class D IVD |
| 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 | Surveillance of requirements for Legacy devices | Notified Bodies | MD |
| MDCG 2022-5 | Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices | Borderline product | Manufacturers | Borderline product |
| MDCG 2022-6 | Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR | Significant change under the transitional provisions | Manufacturers | IVD |
| MDCG 2022-7 | Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | UDI | Manufacturers, systems and procedure packs producers, kit producers | MD, IVD |
| 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 | Transitional provisions | Manufacturers, Authorised representatives, Importers, Distributors, Notified Bodies | IVD |
| MDCG 2022-9 | Summary of safety and performance Template | Safety and performance | Manufacturers | IVD |
| 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) – Mai 2022 | Clinical trials using diagnostic tests | Manufacturers and clinical trials sponsors | IVD and medicines |
| MDCG 2022-11 | MDCG Position Paper Notice to manufacturers to ensure timely compliance with MDR requirements – Juin 2022 | Compliance with MD Regulations | Manufacturers | MD |
| MDCG 2022-12 | 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) – Juillet 2022 | EUDAMED | Economic operators, Notified Bodies, Sponsors, Member States, European Commission | IVDs |
| MDCG 2022-13 | Designation, re-assessment and notification of conformity assessment bodies and notified bodies | Designation of notified bodies | Notified Bodies, Designating Authorities (authorities responsible for notified bodies), Joint Assessment Teams | MD & IVD |
| MDCG 2022-14 | Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs | Transition to the MDR and IVDR | Notified Bodies (NB), Manufacturers | MD & IVD |
| 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 | Surveillance of requirements for Legacy devices | Notified Bodies (NB) | IVD |
| 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) | Authorised representatives in the European Union | Authorised Representatives, Manufacturers and other economic operators | MD & IVD |
| MDCG 2022-17 | MDCG position paper on ‘hybrid audits’ | Hybrid audits | Notified bodies, Manufacturers | MD & IVD |
| 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 | Legacy devices | Manufacturers, Notified bodies | MD |
| MDCG 2022-19 | MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746 | Application/notification for performance studies | Sponsors, Competent authorities | IVD |
| MDCG 2022-20 | Substantial modification of performance study under Regulation (EU) 2017/746 | Substantial modification of performance study | Sponsors, Competent authorities | IVD |
| MDCG 2022-21 | Guidance on periodic safety update report (PSUR) according to regulation (EU) 2017/745 (MDR) | PSUR – Article 86 | Fabricants de dispositifs médicaux de classe IIa, IIb et III | DM |
MDCG 2021
|
Number |
Version and Title | Theme | Target audience | Products concerned |
| MDCG 2021-1 | Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional | EUDAMED | Economic Operators, Notified Bodies, Sponsors, Member-State, European Commission | MD and IVD |
| MDCG 2021-2 | Member-State, European CommissionMD and IVD MDCG Guidance on state of the art of COVID-19 rapid antibody tests | Performance evaluation – COVID-19 | Manufacturers | IVD |
| MDCG 2021-3 | Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices | IVD Custom-Made, Adaptable and Patient-Matched medical devices | Manufacturers | MD |
| MDCG 2021-4 | Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 | Transitional provisions – Conformity Assessment – EURL | Manufacturers, Notified Bodies | Class D IVD |
| MDCG 2021-5 | Guidance on standardisation for medical devices | Harmonised standard, conformity assessment | Manufacturers, Subcontractors, Notified Bodies | MD and IVD |
| MDCG 2021-6 | Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation | Clinical investigation | Sponsors (recital 49) | MD |
| MDCG 2021-7 | Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices | COVID-19 Tests | Manufacturers, Authorised representatives | IVD |
| MDCG 2021-8 | Clinical investigation application/notification documents | Clinical Investigations | Sponsors | MD |
| MDCG 2021-9 | MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers | UDI | Manufacturers | MD (contact lenses, spectacles frames, spectacles lenses and ready readers) |
| MDCG 2021-10 | The status of appendixes E-I of IMDRF N48 under the EU regulatory framework for medical device | UDI | Manufacturers | MD and IVD |
| MDCG 2021-11 | Guidance on implant card ‘Device types’ | Implant Card | Manufacturers | Implantable Medical Device |
| MDCG 2021-12 | FAQ on the European Medical Device Nomenclature (EMDN) | European Medical Device Nomenclature (EMDN) | All actors | MD and IVD |
| 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 | EUDAMED | Actors other than manufacturers, authorised representatives, and importers | MD and IVD |
| MDCG 2021-14 | Explanatory note on IVDR codes | IVDR Codes, Notified Bodies designation scope | Notified Bodies, Manufacturers | IVD |
| Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) 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) |
Designation as notified body | Conformity assessment bodies | MD & IVD | |
| Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) |
Designation as notified body | Conformity assessment bodies | MD & IVD | |
| MDCG 2021-19 | Guidance note integration of the UDI within an organisation’s quality management system | UDI | Manufacturers | MD & IVD |
| MDCG 2021-20 | Instructions for generating CIV-ID for MDR Clinical Investigations | Eudamed2 – clinical investigations | Competent autorities, clinical investigations sponsors | MD |
| MDCG 2021-21 | Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices | COVID 19 – Performance evaluation | All stakeholders | IVD |
| 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 | Expert panel consultation referred to in article 48(6) of Regulation (EU) 2017/746 | Notified bodies, manufacturers | IVD |
| 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 | Certificates | Notified bodies, distributors and importers | MD & IVD |
| MDCG 2021-24 | Guidance on classification of medical devices | MD Classification | Manufacturers and Notified Bodies | MD |
| 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 | Interpretation of the transitional provisions for DM certified under the Directives | Manufacturers, Notified Bodies | MD certified under the directives (IVD excluded) |
| MDCG 2021-26 | Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | Obligations of persons referred to in Article 16 | Importers and distributors | MD & IVD |
| MDCG 2021-27 | Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | Obligations of distributors and importers | Importers and distributors | MD & IVD |
| MDCG 2021-28 | Substantial modification of clinical investigation under Medical Device Regulation | Notification of a substantial modification of clinical investigation | Sponsor of a clinical investigation | MD |
MDCG 2020
|
Number |
Version and Title | Theme | Target audience | Products concerned |
| MDCG 2020-1 | Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software | Clinical Evaluation – Software | Manufacturers | SaMD and Software as a part of a MD |
| MDCG 2020-2 | Class I transitional provisions under Article 120 (3 and 4) – (MDR) | Transitional provisions | Manufacturers | Class I MD (excluding Im, Is) under DIR that change class in accordance with the REG |
| 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 | Transitional provisions – significant changes | Manufacturers, Notified Bodies | Legacy Devices |
| MDCG 2020-4 | Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions | COVID 19 – Audit | Manufacturers, Notified Bodies, Sub-contractors | MD and IVD |
| MDCG 2020-5 | Guidance on clinical evaluation – Equivalence | Clinical Evaluation – Equivalence | Manufacturers | MD and Annex XVI products |
| MDCG 2020-6 | Guidance on sufficient clinical evidence for legacy devices | Clinical Evaluation – Clinical evidence | Manufacturers, Notified Bodies | MD CE marked under the Directives |
| MDCG 2020-7 | Guidance on PMCF plan template | Post-Market Clinical Follow-up | Manufacturers, Notified Bodies | MD (including Legacy Devices) |
| MDCG 2020-8 | Guidance on PMCF evaluation report template | Post-Market Clinical Follow-up | Manufacturers, Notified Bodies | MD (including Legacy Devices) |
| MDCG 2020-9 | Regulatory requirements for ventilators and related accessories | COVID 19 – Ventilators | Manufacturers, Notified Bodies | MD : ventilatiors and their accessories |
| MDCG 2020-10 | MDCG 2020-10/1 : Guidance on safety reporting in clinical investigations + MDCG 2020-10/2 : Appendix: Clinical investigation summary safety report form | Clinical Investigation | Sponsors (Manufacturer, Legal Representative or Contact Person) | Investigational MD |
| 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 | Designation and monitoring of Notified Bodies | Authority responsible for Notified Bodies | MD and AIMD |
| 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 | Specific additional procedures | Notified Bodies | MD as referred to in article 52(9) |
| MDCG 2020-13 | Clinical evaluation assessment report template | Clinical Evaluation | Notified Bodies | MD |
| 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) | Surveillance audits MDR/MDSAP | Notified Bodies | MD and IVD |
| 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 | EUDAMED | Manufacturers, Importers, Authorised representatives, Persons referred to in Article 22 | MD |
| MDCG 2020-16 | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 | IVD Classification | Manufacturers, Notified Bodies | IVD |
| MDCG 2020-17 | Questions and answers related to MDCG 2020-4 | COVID 19 – Audit | Notified Bodies, Manufacturers, Subcontractors | MD and IVD |
| MDCG 2020-18 | MDCG Position Paper on assignment for spectacle lenses and ready readers | UDI – EUDAMED | Manufacturers | Spectacle lenses and ready readers |
MDCG 2019
|
Number |
Version and Title | Theme | Target audience | Products concerned |
| MDCG 2019-1 | MDCG guiding principles for issuing entities rules on basic UDI-DI | Basid UDI-DI | UDI Issuing entities | MD and IVD |
| 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 | UDI – Combination Product | Manufacturers | Combination products (see details) |
| MDCG 2019-3 | REV1 – Interpretation of article 54(2)b | Consultation procedure within the framework of clinical evaluation | Manufacturers, Notified Bodies | Class III implantable MD + Active Class IIb MD intended to deliver/remove a drug to/from the body |
| MDCG 2019-4 | Timelines for registration of device data elements in EUDAMED | EUDAMED | Manufacturers | MD |
| MDCG 2019-5 | Registration of legacy devices in EUDAMED | EUDAMED – Legacy Devices | Manufacturers | Legacy Devices (DM, DMIA and DMDIV) |
| MDCG 2019 | V2 – Questions and answers: Requirements relating to notified bodies | Notified Bodies | Notified Bodies | MD and IVD |
| 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) | Person responsible for regulatory compliance – PRRC | Manufacturers and Authorised representative | MD and IVD |
| MDCG 2019-8 | V2 – Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices | Implant Card | Manufacturers | Implantable MD |
| MDCG 2019-9 | Summary of safety and clinical performance | Summary of Safety and Clinical Performance (SSCP) | Manufacturers, Notified Bodies | Implantable and Class III Devices + Products listed in Annex 16 eligible |
| MDCG 2019-10 | REV1 – Application of transitional provisions concerning validity of certificates issued in accordance to the directives | Transitional provisions | Manufacturers, Notified Bodies | MD and AIMD |
| MDCG 2019-11 | Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | Software and apps qualification and classification | Manufacturers | MD/IVD Software and apps |
| MDCG 2019-12 | Designating authority’s final assessment form: Key information (EN) | Designation of Notified Bodies | Notified Bodies and Conformity Assessment Bodies, Designating authority | MD and IVD |
| MDCG 2019-13 | Guidance on sampling of devices for the assessment of the technical documentation | Conformity Assessment of the Technical Documentation : sampling | Manufacturers, Notified Bodies | Classes IIa and IIb non implantable MD + Classes B and C IVD |
| MDCG 2019-14 | Explanatory note on MDR codes | Designation code of Notified Bodies | Notified Bodies, Designating authorities, Manufacturers | MD |
| MDCG 2019-15 | REV1 – Guidance notes for manufacturers of class I medical devices | Marketing | Manufacturers, Person designated in article 16(1) of the MDR | Class I MD |
| MDCG 2019-16 | REV1 – Guidance on cybersecurity for medical devices | Cybersecurity | Manufacturers | MD that include programmable electronic systems and software that are MD in their own right |
MDCG 2018
|
Number |
Version and Title | Theme | Target audience | Products concerned |
| MDCG 2018-1 | V3 – Guidance on basic UDI-DI and changes to UDI-DI | Basic UDI and UDI-DI | Manufacturers | MD and IVD |
| MDCG 2018-2 | Future EU medical device nomenclature – Description of requirements | European Medical Device Nomenclature (EMDN) | All actors | MD and IVD |
| MDCG 2018-3 | Guidance on UDI for systems and procedure packs | UDI – Systems and procedure pack | Systems and procedure pack producer (persons reffered to in article 22) | MD |
| MDCG 2018-4 | Definitions/descriptions and formats of the UDI core elements for systems or procedure packs | UDI – Systems and procedure pack | Systems and procedure pack producer (persons reffered to in article 22) | MD |
| MDCG 2018-5 | UDI assignment to medical device software | UDI – MD software | Manufacturers | MD and IVD |
| MDCG 2018-6 | Clarifications of UDI related responsibilities in relation to article 16 | Obligations of persons referred to in article 16 | Persons referred to in article 16 | MD and IVD |
| MDCG 2018-7 | Provisional considerations regarding language issues associated with the UDI database | EUDAMED – UDI database | Manufacturers | MD and IVD |
| MDCG 2018-8 | Guidance on content of the certificates, voluntary certificate transfers | Certificates | Notified Bodies | MD and IVD |