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
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
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
