MDCG Endorsed documents

The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.

Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the EU.

UDI

MDCG 2018-3    Guidance on UDI for systems and procedure packs   
MDCG 2018-1    Guidance on basic UDI-DI and changes to UDI-DI    
MDCG 2019-1    MDCG guiding principles for issuing entities rules on basic UDI-DI    
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    
MDCG 2018-2    Future EU medical device nomenclature - Description of requirements    
MDCG 2018-4    Definitions/descriptions and formats of the UDI core elements for systems or procedure packs   
MDCG 2018-5    UDI assignment to medical device software   
MDCG 2018-6    Clarifications of UDI related responsibilities in relation to article 16    
MDCG 2018-7    Provisional considerations regarding language issues associated with the UDI database    

EUDAMED

MDCG 2019-4    Timelines for registration of device data elements in EUDAMED    
MDCG 2019-5    Registration of legacy devices in EUDAMED   

Notified bodies

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    
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   
MDCG 2020-4    Guidance on temporary extraordinary measures related to medical device notified body audits during

                             COVID-19 quarantine orders and travel restrictions   
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    
MDCG 2019-14    Explanatory note on MDR codes    
MDCG 2019-13    Guidance on sampling of devices for the assessment of the technical documentation    
MDCG 2019-12    Designating authority's final assessment form: Key information (EN)    
MDCG 2019-10    Application of transitional provisions concerning validity of certificates issued in accordance to the

                              directives    
MDCG 2019-6     Questions and answers: Requirements relating to notified bodies    
MDCG 2018-8    Guidance on content of the certificates, voluntary certificate transfers    
NBOG BPG 2017-1    Best practice guidance on designation and notification of conformity assessment bodies    
NBOG BPG 2017-2    Best practice guidance on the information required for personnel involved in conformity

                                   assessment    
NBOG F 2017-1    Application form to be submitted by a conformity assessment body when applying for designation as

                              notified body under the medical devices regulation (MDR)    
NBOG F 2017-2    Application form to be submitted by a conformity assessment body when applying for designation as a

                              notified body under the in vitro diagnostic devices regulation (IVDR)    
NBOG F 2017-3    Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU)

                              2017/745 (MDR)    
NBOG F 2017-4    Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU)

                              2017/746 (IVDR)    
NBOG F 2017-5    Preliminary assessment review template (MDR)    
NBOG F 2017-6    Preliminary assessment review template (IVDR)    
NBOG F 2017-7    Review of qualification for the authorisation of personnel (MDR)    
NBOG F 2017-8    Review of qualification for the authorisation of personnel (IVDR)    

Clinical investigation and evaluation

MDCG 2020-13      Clinical evaluation assessment report template    
MDCG 2020-10/1  Guidance on safety reporting in clinical investigations
MDCG 2020-10/2  Appendix: Clinical investigation summary safety report form    

MDCG 2020-8       Guidance on PMCF evaluation report template    
MDCG 2020-7        Guidance on PMCF plan template    
MDCG 2020-6       Guidance on sufficient clinical evidence for legacy devices    
MDCG 2020-5       Guidance on clinical evaluation – Equivalence    
MDCG 2019-9       Summary of safety and clinical performance   

New technologies

MDCG 2020-1    Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software    
MDCG 2019-11    Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746    
MDCG 2019-16    Guidance on cybersecurity for medical devices    

Other topics

MDCG 2020-9    Regulatory requirements for ventilators and related accessories    
MDCG 2019-3     Interpretation of article 54(2)b    
MDCG 2020-2    Class I transitional provisions under Article 120 (3 and 4) – (MDR)    
MDCG 2019-8    Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices    
MDCG 2019-15  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

Other guidance documents

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

Commission guidance documents

-  Conformity assessment procedures for protective equipment    
-  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    
-  Guidance on regulatory requirements for medical face masks    
-  Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the

                COVID-19 context    
-  Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for

                COVID-19    

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