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Guidance - MDCG endorsed documents and other guidance

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MDCG work in progress

Ongoing guidance documents

Borderline and Classification

ReferenceTitle
Publication

MDCG 2021-24

Guidance on classification of medical devices
October 2021

Helsinki Procedure

Helsinki Procedure for borderline and classification under MDR & IVDR
September 2021

Clinical investigation and evaluation

ReferenceTitle
Publication

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

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

MDCG 2020-13 - Word version

Clinical evaluation assessment report template
July 2020
MDCG 2020-10/2

MDCG 2020-10/1

Guidance on safety reporting in clinical investigations
Appendix: Clinical investigation summary safety report form
May 2020
May 2020
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 Summary of safety and clinical performance
August 2019

COVID-19

ReferenceTitle
Publication
MDCG 2022-1 Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
January 2022
MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
August 2021
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 )
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

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

EUDAMED

ReferenceTitle
Publication
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)

ReferenceTitle
Publication
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

Implant cards

ReferenceTitle
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 Vitro Diagnostic medical devices (IVD)

ReferenceTitle
Publication
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
August 2021
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.1 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
January 2022

New technologies

ReferenceTitle
Publication
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

ReferenceTitle
Publication
MDCG 2019-6 Rev.3 Questions and answers: Requirements relating to notified bodies
October 2021
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 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
March 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 BPG 2017-1 Best practice guidance on designation and notification of conformity assessment bodies
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

Standards

ReferenceTitle
Publication
MDCG 2021-5 Guidance on standardisation for medical devices
April 2021

Unique Device Identifier (UDI)

ReferenceTitle
Publication
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
MDCG 2018-2 Future EU medical device nomenclature - Description of requirements
March 2018

Other topics

ReferenceTitle
Publication

MDCG 2021-27

Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746,  requirements related to importers and distributors under Regulation (EU) 2017/745
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
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 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
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 Interpretation of article 54(2)b
April 2020

Other guidance documents

ReferenceTitle
Publication
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