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.

Ongoing guidance documents

Annex XVI products

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

Borderline and Classification

Reference	Title	Publication
Manual on Borderline	Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v3 Background note on the use of the Manual on borderline and classification for medical devices under the Directives.	September 2023
MDCG 2024-13	Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices	October 2024
MDCG 2022-5 rev.1	Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices	October 2024
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	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

Clinical investigation and evaluation

Reference	Title	Publication
MDCG 2024-10	Clinical evaluation of orphan medical devices	June 2024
MDCG 2024-5 MDCG 2024-5 Appendix A	Guidance on the Investigator’s Brochure content Appendix A of the MDCG 2024-5	April2024 April2024
MDCG 2024-3 MDCG 2024-3 Appendix A	Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices Clinical Investigation Plan Synopsis Template	March 2024 March 2024
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	December 2023
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	December 2023
MDCG 2020-13 - Word version	Clinical evaluation assessment report template	July 2020
MDCG 2020-10/1 rev.1 MDCG 2020-10/2 rev.1	Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form	October 2022 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 Background note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluation	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	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

Custom-Made Devices

Reference	Title	Publication
MDCG 2021-3	Questions and Answers on Custom-Made Devices	March 2021

EUDAMED

EUDAMED Information Centre

Reference	Title	Publication
Gradual roll out of EUDAMED	Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices1	November 2024
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	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

Implant cards

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

In-house devices

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

Authorised Representatives, Importers, Distributors

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

In Vitro Diagnostic medical devices (IVD)

Reference	Title	Publication
MDCG 2024-11	Guidance on qualification of in vitro diagnostic medical devices	October 2024
MDCG 2024-4 MDCG 2024-4 Appendix	Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 Appendix – Performance Study Summary Safety Reporting Form	April 2024
MDCG 2022-9 rev.1	Summary of safety and performance template	April 2024
MDCG 2020-16 rev.3	Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746	July 2024
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 2022-8	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 rev.1	Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746	September 2024

New technologies

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

Notified bodies

Reference	Title	Publication
MDCG 2024-6	Preliminary re-assessment review (PRAR) form template (MDR)	May 2024
MDCG 2024-7	Preliminary assessment review (PAR) form template (MDR)	May 2024
MDCG 2024-8	Preliminary assessment review (PAR) form template (IVDR)	May 2024
MDCG 2024-9	Preliminary re-assessment review (PRAR) form template (IVDR)	May 2024
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 Note to the reader: Due to technical issues, please disregard the document displayed from 7 September 2023 until 8 September 2023.	September 2023
MDCG 2023-2 MDCG 2023-2 MDR form MDCG 2023-2 IVDR form	List of Standard Fees	January 2023
MDCG 2022-4 rev.2	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	May 2024
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 rev.1	Designation, re-assessment and notification of conformity assessment bodies and notified bodies	June 2024
MDCG 2024-12 MDCG 2024-12 Annex I Form MDCG 2024-12 Annex II Form	Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams Annex I: Template CAPA plan and assessment thereon Annex II: Template JAT review of the CAPA and the DA's opinion	October 2024
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

Person responsible for regulatory compliance (PRRC)

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

Post-Market Surveillance and Vigilance (PMSV)

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 rev.1	Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746	November 2024
MDCG 2022-21	Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745	December 2022

Standards

Reference	Title	Publication
MDCG 2021-5 rev.1	Guidance on standardisation for medical devices	July 2024

Unique Device Identifier (UDI)

UDI Helpdesk

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 rev.1	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 2024
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