32 documents as of December 2019
MDCG work in progress
Ongoing guidance documents
UDI
Title Publication Date M DCG 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 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI February 2019 MDCG 2018-2 Future EU medical device nomenclature – Description of requirements March 2018 MDCG 2018-3 Guidance on UDI for systems and procedure packs October 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
Title Publication Date 2019-4 Timelines for registration of device data elements in EUDAMED April 2019 2019-5 Registration of legacy devices in EUDAMED April 2019
Notified bodies
Title Publication Date 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 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
Title Publication Date MDCG 2019-9 Summary of safety and clinical performance August 2019
New technologies
Title Publication Date MDCG 2019-11 Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 October 2019
Other topics
Title Publication Date 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 MDCG 2019-8 Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices June 2019 MDCG 2019-3 Interpretation of article 54(2)b March 2019
Other guidance documents
Title Publication Date SCHEER guidelines Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices June 2019