32 documents as of December 2019

MDCG work in progress

Ongoing guidance documents

UDI
TitlePublicationDate
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 2018-1 v2Guidance on basic UDI-DI and changes to UDI-DIFebruary 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
TitlePublicationDate
2019-4Timelines for registration of device data elements in EUDAMEDApril 2019
2019-5Registration of legacy devices in EUDAMEDApril 2019
Notified bodies
TitlePublicationDate
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 assessment  February 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
TitlePublicationDate
MDCG 2019-9Summary of safety and clinical performanceAugust 2019
New technologies
TitlePublicationDate
MDCG 2019-11Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2019
Other topics
TitlePublicationDate
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
MDCG 2019-8Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devicesJune 2019
MDCG 2019-3Interpretation of article 54(2)bMarch 2019

Other guidance documents

TitlePublicationDate
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