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Guidance - MDCG endorsed documents and other guidance

This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices. 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.

MDCG work in progress

Ongoing guidance documents

Borderline and Classification

ReferenceTitlePublication
Manual on Borderline

Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v1

Background note on the use of the Manual on borderline and classification for medical devices under the Directives.

September 2022

MDCG 2022-5

Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devicesApril 2022

MDCG 2021-24

Guidance on classification of medical devicesOctober 2021

Helsinki Procedure

Helsinki Procedure for borderline and classification under MDR & IVDRSeptember 2021

Class I Devices

ReferenceTitlePublication
MDCG 2020-2 rev.1Class I transitional provisions under Article 120 (3 and 4) – (MDR)March 2020
MDCG 2019-15 rev.1Guidance notes for manufacturers of class I medical devicesDecember 2019

Clinical investigation and evaluation

ReferenceTitlePublication

MDCG 2021-28

Substantial modification of clinical investigation under Medical Device RegulationDecember 2021

MDCG 2021-20

Instructions for generating CIV-ID for MDR Clinical InvestigationsJuly 2021

MDCG 2021-8

Clinical investigation application/notification documentsMay 2021

MDCG 2021-6

Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigationApril 2021

MDCG 2020-13 - Word version

Clinical evaluation assessment report templateJuly 2020
MDCG 2020-10/1

MDCG 2020-10/2

Guidance on safety reporting in clinical investigations
Appendix: Clinical investigation summary safety report form
May 2020
May 2020
MDCG 2020-8Guidance on PMCF evaluation report templateApril 2020
MDCG 2020-7Guidance on PMCF plan templateApril 2020
MDCG 2020-6

Guidance on sufficient clinical evidence for legacy devices

Background noteon the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluation

April 2020
MDCG 2020-5Guidance on clinical evaluation – EquivalenceApril 2020
MDCG 2019-9 - Rev.1Summary of safety and clinical performanceMarch 2022

COVID-19

ReferenceTitlePublication
MDCG 2022-1Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devicesJanuary 2022
MDCG 2021-21 Rev.1Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devicesAugust 2021
MDCG 2021-7Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devicesMay 2021
MDCG 2021-2Guidance on state of the art of COVID-19 rapid antibody testsMarch 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 equipmentJuly 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 contextMay 2020
Guidance on regulatory requirements for medical face masksJune 2020
Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 contextApril 2020
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19April 2020
MDCG 2020-9Regulatory requirements for ventilators and related accessoriesApril 2020

Custom-Made Devices

ReferenceTitlePublication
MDCG 2021-3Questions and Answers on Custom-Made DevicesMarch 2021

EUDAMED

ReferenceTitlePublication
MDCG 2022-12Guidance 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. 1Questions 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 IVDRJuly 2021
MDCG 2021-1 Rev. 1Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functionalMay 2021
MDCG 2020-15MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member StatesAugust 2020
MDCG 2019-5Registration of legacy devices in EUDAMEDApril 2019
MDCG 2019-4Timelines for registration of device data elements in EUDAMEDApril 2019

European Medical Device Nomenclature (EMDN)

ReferenceTitlePublication
MDCG 2021-12FAQ on the European Medical Device Nomenclature (EMDN)June 2021
The EMDN – The nomenclature of use in EUDAMEDJanuary 2020
The CND nomenclature – Background and general principlesJanuary 2020
MDCG 2018-2Future EU medical device nomenclature - Description of requirementsMarch 2018

Implant cards

ReferenceTitlePublication
MDCG 2021-11Guidance on Implant Card – Device typesMay 2021
MDCG 2019-8 v2Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devicesMarch 2020

Importers & Distributors

ReferenceTitlePublication

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)

ReferenceTitlePublication
MDCG 2022-15Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDDSeptember  2022
MDCG 2021-22 rev.1Clarification 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) 2017/746September  2022
MDCG 2022-10Q&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 2022-9Summary of safety and performance templateMay 2022
MDCG 2022-8Regulation (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/ECMay 2022
MDCG 2022-6Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDRMay 2022
MDCG 2022-3Verification of manufactured class D IVDs by notified bodiesFebruary 2022
MDCG 2022-2Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)January 2022
MDCG 2021-4Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746April 2021
MDCG 2020-16 Rev.1Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746January 2022

New technologies

ReferenceTitlePublication
InfographicIs your software a Medical Device?March 2021
MDCG 2020-1Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device softwareMarch 2020
MDCG 2019-16 rev.1Guidance on cybersecurity for medical devicesDecember 2019
MDCG 2019-11Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2019

Notified bodies

ReferenceTitlePublication
MDCG 2022-13Designation, re-assessment and notification of conformity assessment bodies and notified bodiesAugust 2022
MDCG 2022-4Guidance 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 AIMDDFebruary 2022
MDCG 2019-6 Rev.3Questions and answers: Requirements relating to notified bodiesOctober 2021
MDCG 2021-23Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746August 2021
MDCG 2021-18Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)July 2021
MDCG 2021-17Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)July 2021
MDCG 2021-16Application 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 2021-15Application 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 2021-14Explanatory note on IVDR codesJuly 2021
MDCG 2020-17Questions 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 2020-14Guidance 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 2020-12Guidance 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 tissuesJune 2020
MDCG 2020-11Guidance 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) 920/2013May 2020
MDCG 2020-4Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictionsApril 2020
MDCG 2020-3Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDDMarch 2020
MDCG 2019-14Explanatory note on MDR codesDecember 2019
MDCG 2019-13Guidance on sampling of devices for the assessment of the technical documentationDecember 2019
MDCG 2019-12Designating authority's final assessment form: Key information (EN)October 2019
MDCG 2019-10 rev.1Application of transitional provisions concerning validity of certificates issued in accordance to the directivesOctober 2019
MDCG 2018-8Guidance on content of the certificates, voluntary certificate transfersNovember 2018
NBOG BPG 2017-2Best practice guidance on the information required for personnel involved in conformity assessmentFebruary 2018
NBOG F 2017-8Review of qualification for the authorisation of personnel (IVDR)February 2018
NBOG F 2017-7Review of qualification for the authorisation of personnel (MDR)February 2018
NBOG F 2017-6Preliminary assessment review template (IVDR)February 2018
NBOG F 2017-5Preliminary assessment review template (MDR)February 2018

Standards

ReferenceTitlePublication
MDCG 2021-5Guidance on standardisation for medical devicesApril 2021

Unique Device Identifier (UDI)

ReferenceTitlePublication
MDCG 2022-7Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU)May 2022
MDCG 2021-19Guidance note integration of the UDI within an organisation’s quality management systemJuly 2021
MDCG 2021-10The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devicesJune 2021
MDCG 2021-09MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readersMay 2021
MDCG 2018-1 Rev. 4Guidance on basic UDI-DI and changes to UDI-DIApril 2021
MDCG 2020-18MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readersDecember 2020
MDCG 2019-2Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017February 2019
MDCG 2019-1MDCG guiding principles for issuing entities rules on basic UDI-DIJanuary 2019
MDCG 2018-7Provisional considerations regarding language issues associated with the UDI databaseOctober 2018
MDCG 2018-6Clarifications of UDI related responsibilities in relation to article 16October 2018
MDCG 2018-5UDI assignment to medical device softwareOctober 2018
MDCG 2018-4Definitions/descriptions and formats of the UDI core elements for systems or procedure packsOctober 2018
MDCG 2018-3 Rev.1Guidance on UDI for systems and procedure packsJune 2020

Other topics

ReferenceTitlePublication
MDCG 2022-14Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDsAugust 2022
MDCG 2022-11MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirementsJune 2022
MDCG 2021-25Application 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/EECOctober 2021
MDCG 2019-7Guidance 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

ReferenceTitlePublication
European Medicines Agency (EMA) GuidanceQuestions & 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 guidelinesGuidelines 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 FAQCAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisionsJanuary 2018