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.
| Title | Publication | Date |
|---|---|---|
| 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 2018-1 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 |
| 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 |
| Title | Publication | Date |
|---|---|---|
| MDCG 2019-6 | Questions and answers: Requirements relating to notified bodies | June 2019 |
| 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 |
| Title | Publication | Date |
|---|---|---|
| MDCG 2019-3 | Interpretation of article 54(2)b | March 2019 |