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 documents

MDCG endorsed 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 2019-6Questions and answers: Requirements relating to notified bodiesJune 2019
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

Other topics

TitlePublicationDate
MDCG 2019-3Interpretation of article 54(2)bMarch 2019