Internal Market, Industry, Entrepreneurship and SMEs

Guidance

Guidance

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 endorsed documents

MDCG work in progress

Ongoing guidance documents

UDI
ReferenceTitlePublication
MDCG 2018-1 v3Guidance on basic UDI-DI and changes to UDI-DIMarch 2020
MDCG 2019-1MDCG guiding principles for issuing entities rules on basic UDI-DIJanuary 2019
MDCG 2019-2Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017February 2019
MDCG 2018-2Future EU medical device nomenclature - Description of requirementsMarch 2018
MDCG 2018-3Guidance on UDI for systems and procedure packsOctober 2018
MDCG 2018-4Definitions/descriptions and formats of the UDI core elements for systems or procedure packsOctober 2018
MDCG 2018-5UDI assignment to medical device softwareOctober 2018
MDCG 2018-6Clarifications of UDI related responsibilities in relation to article 16October 2018
MDCG 2018-7Provisional considerations regarding language issues associated with the UDI databaseOctober 2018
EUDAMED
ReferenceTitlePublication
MDCG 2019-4Timelines for registration of device data elements in EUDAMEDApril 2019
MDCG 2019-5Registration of legacy devices in EUDAMEDApril 2019
European Medical Device Nomenclature (EMDN)
TitlePublication
The EMDN – The nomenclature of use in EUDAMEDJanuary 2020
The CND nomenclature – Background and general principlesJanuary 2020
Notified bodies
ReferenceTitlePublication
MDCG 2020-4Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictionsApril 2020
MDCG 2020-3Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDDMarch 2020
MDCG 2019-14Explanatory note on MDR codesDecember 2019
MDCG 2019-13Guidance on sampling of devices for the assessment of the technical documentationDecember 2019
MDCG 2019-12Designating authority's final assessment form: Key information (EN)October 2019
MDCG 2019-10Application of transitional provisions concerning validity of certificates issued in accordance to the directivesOctober 2019
MDCG 2019-6 v2Questions and answers: Requirements relating to notified bodiesOcotober2019
MDCG 2018-8Guidance on content of the certificates, voluntary certificate transfersNovember 2018
NBOG BPG 2017-1Best practice guidance on designation and notification of conformity assessment bodiesFebruary 2018
NBOG BPG 2017-2Best practice guidance on the information required for personnel involved in conformity assessmentFebruary 2018
NBOG F 2017-1Application 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 2017-2Application 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 2017-3Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)February 2018
NBOG F 2017-4Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)February 2018
NBOG F 2017-5Preliminary assessment review template (MDR)February 2018
NBOG F 2017-6Preliminary assessment review template (IVDR)February 2018
NBOG F 2017-7Review of qualification for the authorisation of personnel (MDR)February 2018
NBOG F 2017-8Review of qualification for the authorisation of personnel (IVDR)February 2018
Clinical investigation and evaluation
ReferenceTitlePublication

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 2020-8Guidance on PMCF evaluation report templateApril 2020
MDCG 2020-7Guidance on PMCF plan templateApril 2020
MDCG 2020-6Guidance on sufficient clinical evidence for legacy devicesApril 2020
MDCG 2020-5Guidance on clinical evaluation – EquivalenceApril 2020
MDCG 2019-9Summary of safety and clinical performanceAugust 2019
New technologies
ReferenceTitlePublication
MDCG 2020-1Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device softwareMarch 2020
MDCG 2019-11Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2019
MDCG 2019-16Guidance on cybersecurity for medical devicesDecember 2019
Other topics
ReferenceTitlePublication
MDCG 2020-9Regulatory requirements for ventilators and related accessoriesApril 2020
MDCG 2019-3 rev.1Interpretation of article 54(2)bApril 2020
MDCG 2020-2Class I transitional provisions under Article 120 (3 and 4) – (MDR)March 2020
MDCG 2019-8 v2Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devicesMarch 2020
MDCG 2019-15Guidance notes for manufacturers of class I medical devicesDecember 2019
MDCG 2019-7Guidance 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

ReferenceTitlePublication
SCHEER guidelinesGuidelines 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