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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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
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 2019-6 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 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 REV1 – 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