Medical Devices - Sector

Guidance - MDCG endorsed documents

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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.

MDCG work in progress

Ongoing guidance documents

UDI

Reference Title Publication
MDCG 2018-3 Rev.1 Guidance on UDI for systems and procedure packs June 2020
MDCG 2018-1 v3 Guidance on basic UDI-DI and changes to UDI-DI March 2020
MDCG 2019-1 MDCG guiding principles for issuing entities rules on basic UDI-DI January 2019
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 2018-2 Future EU medical device nomenclature - Description of requirements March 2018
MDCG 2018-4 Definitions/descriptions and formats of the UDI core elements for systems or procedure packs October 2018
MDCG 2018-5 UDI assignment to medical device software October 2018
MDCG 2018-6 Clarifications of UDI related responsibilities in relation to article 16 October 2018
MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database October 2018

EUDAMED

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

European Medical Device Nomenclature (EMDN)

Title Publication
The EMDN – The nomenclature of use in EUDAMED January 2020
The CND nomenclature – Background and general principles January 2020

Notified bodies

Reference Title Publication
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 2019-6 v2 Questions and answers: Requirements relating to notified bodies Ocotober2019
MDCG 2018-8 Guidance on content of the certificates, voluntary certificate transfers November 2018
NBOG BPG 2017-1 Best practice guidance on designation and notification of conformity assessment bodies February 2018
NBOG BPG 2017-2 Best practice guidance on the information required for personnel involved in conformity assessment February 2018
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) February 2018
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) February 2018
NBOG F 2017-3 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) February 2018
NBOG F 2017-4 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) February 2018
NBOG F 2017-5 Preliminary assessment review template (MDR) February 2018
NBOG F 2017-6 Preliminary assessment review template (IVDR) February 2018
NBOG F 2017-7 Review of qualification for the authorisation of personnel (MDR) February 2018
NBOG F 2017-8 Review of qualification for the authorisation of personnel (IVDR) February 2018

Clinical investigation and evaluation

Reference Title Publication

MDCG 2020-13 - Word version

Clinical evaluation assessment report template July 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 2020-8 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

New technologies

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

Other topics

Reference Title Publication
MDCG 2020-9 Regulatory requirements for ventilators and related accessories April 2020
MDCG 2019-3 rev.1 Interpretation of article 54(2)b April 2020
MDCG 2020-2 rev.1 Class I transitional provisions under Article 120 (3 and 4) – (MDR) March 2020
MDCG 2019-8 v2 Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices 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

Commission guidance documents

Title Publication
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

Other guidance documents

Reference Title Publication
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