Guidance - MDCG endorsed documents and other guidance
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The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations, including documents endorsed by the Medical Device Coordination Group (MDCG) and other informative texts.
Legally non-binding guidance documents, adopted by the 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 work in progress
Clinical investigation and evaluation
| Reference | Title | Publication |
|---|---|---|
| Clinical evaluation assessment report template | July 2020 | |
| MDCG 2020-10/2 | 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 |
COVID-19
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-2 | Guidance on state of the art of COVID-19 rapid antibody tests | March 2021 |
| COVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 | February 2021 | |
| Conformity assessment procedures for protective equipment | July 2020 | |
| How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context | May 2020 | |
| Guidance on regulatory requirements for medical face masks | June 2020 | |
| Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context | April 2020 | |
| Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19 | April 2020 | |
| MDCG 2020-9 | Regulatory requirements for ventilators and related accessories | April 2020 |
Custom-Made Devices
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-3 | Questions and Answers on Custom-Made Devices | March 2021 |
EUDAMED
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-1 | Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional | February 2021 |
| MDCG 2020-15 | MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States | August 2020 |
| MDCG 2019-5 | Registration of legacy devices in EUDAMED | April 2019 |
| MDCG 2019-4 | Timelines for registration of device data elements in EUDAMED | April 2019 |
European Medical Device Nomenclature (EMDN)
| Title | Publication |
|---|---|
| The EMDN – The nomenclature of use in EUDAMED | January 2020 |
| The CND nomenclature – Background and general principles | January 2020 |
In Vitro Diagnostic medical devices (IVD)
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-4 | Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 | April 2021 |
| MDCG 2020-16 | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 | November 2020 |
New technologies
| Reference | Title | Publication |
|---|---|---|
| Infographic | Is your software a Medical Device? | March 2021 |
| MDCG 2020-1 | Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software | March 2020 |
| MDCG 2019-16 rev.1 | Guidance on cybersecurity for medical devices | December 2019 |
| MDCG 2019-11 | Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | October 2019 |
Notified bodies
| Reference | Title | Publication |
|---|---|---|
| MDCG 2020-17 | Questions and Answers related to MDCG 2020-4: “Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions” |
December 2020 |
| MDCG 2020-14 | Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) | August 2020 |
| MDCG 2020-12 | Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues | June 2020 |
| MDCG 2020-11 | Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013 | May 2020 |
| 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 rev.1 | 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 | October2019 |
| MDCG 2018-8 | Guidance on content of the certificates, voluntary certificate transfers | November 2018 |
| NBOG BPG 2017-2 | Best practice guidance on the information required for personnel involved in conformity assessment | February 2018 |
| NBOG BPG 2017-1 | Best practice guidance on designation and notification of conformity assessment bodies | February 2018 |
| NBOG F 2017-8 | Review of qualification for the authorisation of personnel (IVDR) | February 2018 |
| NBOG F 2017-7 | Review of qualification for the authorisation of personnel (MDR) | February 2018 |
| NBOG F 2017-6 | Preliminary assessment review template (IVDR) | February 2018 |
| NBOG F 2017-5 | Preliminary assessment review template (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 2017-3 | Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (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 2017-1 | 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 |
Unique Device Identifier (UDI)
| Reference | Title | Publication |
|---|---|---|
| MDCG 2020-18 | MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers | December 2020 |
| 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 2019-1 | MDCG guiding principles for issuing entities rules on basic UDI-DI | January 2019 |
| MDCG 2018-7 | Provisional considerations regarding language issues associated with the UDI database | October 2018 |
| MDCG 2018-6 | Clarifications of UDI related responsibilities in relation to article 16 | October 2018 |
| MDCG 2018-5 | UDI assignment to medical device software | October 2018 |
| MDCG 2018-4 | Definitions/descriptions and formats of the UDI core elements for systems or procedure packs | October 2018 |
| MDCG 2018-3 Rev.1 | Guidance on UDI for systems and procedure packs | June 2020 |
| MDCG 2018-2 | Future EU medical device nomenclature - Description of requirements | March 2018 |
| MDCG 2018-1 v3 | Guidance on basic UDI-DI and changes to UDI-DI | March 2020 |
Other topics
| Reference | Title | Publication |
|---|---|---|
| MDCG 2020-2 rev.1 | Class I transitional provisions under Article 120 (3 and 4) – (MDR) | March 2020 |
| MDCG 2019-15 rev.1 | Guidance notes for manufacturers of class I medical devices | December 2019 |
| MDCG 2019-8 v2 | Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices | March 2020 |
| MDCG 2019-7 | 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 2019-3 rev.1 | Interpretation of article 54(2)b | April 2020 |
Other guidance documents
| 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 |
| CAMD FAQ | CAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisions | January 2018 |
Najnovije vijesti
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