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.
| Reference | Title | Publication |
|---|---|---|
| MDCG 2018-1 v3 | Guidance on basic UDI-DI and changes to UDI-DI | March 2020 |
| 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 2018-2 | 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 |
| Reference | Title | Publication |
|---|---|---|
| MDCG 2019-4 | Timelines for registration of device data elements in EUDAMED | April 2019 |
| MDCG 2019-5 | Registration of legacy devices in EUDAMED | April 2019 |
| Title | Publication |
|---|---|
| The EMDN – The nomenclature of use in EUDAMED | January 2020 |
| The CND nomenclature – Background and general principles | January 2020 |
| Reference | Title | Publication |
|---|---|---|
| MDCG 2020-4 | Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions | April 2020 |
| MDCG 2020-3 | Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD | March 2020 |
| 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 |
| Reference | Title | Publication |
|---|---|---|
| Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form | May 2020 May 2020 | |
| MDCG 2020-8 | Guidance on PMCF evaluation report template | April 2020 |
| MDCG 2020-7 | Guidance on PMCF plan template | April 2020 |
| MDCG 2020-6 | Guidance on sufficient clinical evidence for legacy devices | April 2020 |
| MDCG 2020-5 | Guidance on clinical evaluation – Equivalence | April 2020 |
| MDCG 2019-9 | Summary of safety and clinical performance | August 2019 |
| Reference | Title | Publication |
|---|---|---|
| MDCG 2020-1 | Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software | March 2020 |
| MDCG 2019-11 | Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | October 2019 |
| MDCG 2019-16 | Guidance on cybersecurity for medical devices | December 2019 |
| Reference | Title | Publication |
|---|---|---|
| MDCG 2020-9 | Regulatory requirements for ventilators and related accessories | April 2020 |
| MDCG 2019-3 rev.1 | Interpretation of article 54(2)b | April 2020 |
| MDCG 2020-2 | Class I transitional provisions under Article 120 (3 and 4) – (MDR) | March 2020 |
| MDCG 2019-8 v2 | Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices | March 2020 |
| MDCG 2019-15 | Guidance notes for manufacturers of class I medical devices | December 2019 |
| 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 |
| Reference | Title | Publication |
|---|---|---|
| SCHEER guidelines | Guidelines 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 |
