MDCG guidance documents – IVDR

The Medical Device Coordination Group (MDCG) is a regulatory body of health and industry experts with the goal to improve medical device coordination, ensuring the safe and effective use of medical devices in Europe. The MDCG guidance provides information about the provisions that must be addressed for the implementation of the IVDR. While the guidance is not legally binding, it implements Article 105 of the EU MDR intended for the harmonized and effective execution of the regulations.

MDCG work in progress: Ongoing guidance documents

Below you can download the published MDCG guidance documents that are relevant for In Vitro Diagnostic Medical Devices in the European Union.

In Vitro Diagnostic medical devices (IVD)

MDCG 2022-20: Substantial modification of performance study under Regulation (EU) 2017/746

Publication date: December 2022

MDCG 2022-19: Performance study application/notification documents under Regulation (EU) 2017/746

Publication date: December 2022

MDCG 2022-15: Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD

Publication date: September 2022

MDCG 2021-22: Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746

Publication date: September 2022

MDCG 2022-10: Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

Publication date: May 2022

MDCG 2022-9: Summary of safety and performance template

Publication date: May 2022

MDCG 2022-8: Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC

Publication date: May 2022

MDCG 2022-6: Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

Publication date: May 2022

MDCG 2022-3: Verification of manufactured class D IVDs by notified bodies

Publication date: February 2022

MDCG 2022-2: Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)

Publication date: January 2022

MDCG 2021-4: Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746

Publication date: April 2021

MDCG 2020-16: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

Publication date: February 2023

Software

Is your software a Medical Device?

Publication date: March 2021

MDCG 2020-1: Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software

Publication date: March 2020

MDCG 2019-16: Guidance on cybersecurity for medical devices

Publication date: December 2019

MDCG 2019-11: Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Publication date: October 2019

Post-Market Surveillance and Vigilance (PMSV)

Unique Device Identifier (UDI)

MDCG 2022-7: Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU)

Publication date: May 2022

MDCG 2021-19: Guidance note integration of the UDI within an organisation’s quality management system

Publication date: July 2021

MDCG 2021-10: The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices

Publication date: June 2021

MDCG 2018-1: Guidance on basic UDI-DI and changes to UDI-DI

Publication date: April 2021

MDCG 2019-1: MDCG guiding principles for issuing entities rules on basic UDI-DI

Publication date: January 2019

MDCG 2018-7: Provisional considerations regarding language issues associated with the UDI database

Publication date: October 2018

MDCG 2018-6: Clarifications of UDI related responsibilities in relation to article 16

Publication date: October 2018

MDCG 2018-5: UDI assignment to medical device software

Publication date: October 2018

Standards

MDCG 2021-5: Guidance on standardisation for medical devices

Publication date: April 2021

In-house devices

MDCG 2023-1: Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Publication date: January 2023

Borderline and Classification

Manual on borderline and classification under MDR & IVDR

Publication date: December 2022

Helsinki Procedure for borderline and classification under MDR & IVDR

Publication date: September 2021

Authorised Representatives, Importers, Distributors

MDCG 2022-16: Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Publication date: October 2022

MDCG 2021-27: Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Publication date: December 2021

MDCG 2021-26: Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Publication date: October 2021

EUDAMED

MDCG 2022-12: Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)

Publication date: July 2022

MDCG 2021-13: Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR

Publication date: July 2021

MDCG 2019-4: Timelines for registration of device data elements in EUDAMED

Publication date: April 2019

European Medical Device Nomenclature (EMDN)

MDCG 2021-12: FAQ on the European Medical Device Nomenclature (EMDN)

Publication date: June 2021

The EMDN – The nomenclature of use in EUDAMED

Publication date: January 2020

The CND nomenclature – Background and general principles

Publication date: January 2020

MDCG 2018-2: Future EU medical device nomenclature - Description of requirements

Publication date: March 2018

Other topics

Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

Publication date: July 2023

MDCG 2022-14: Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs

Publication date: August 2022

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)

Publication date: June 2019

Notified Bodies (NoBo)

MDCG 2022-17: MDCG position paper on "hybrid audits"

Publication date: December 2022

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

Publication date: October 2022

MDCG 2022-13: Designation, re-assessment and notification of conformity assessment bodies and notified bodies

Publication date: August 2022

MDCG 2021-23: Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Publication date: August 2021

MDCG 2021-18: Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)

Publication date: July 2021

MDCG 2021-16: Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)

Publication date: July 2021

MDCG 2021-14: Explanatory note on IVDR codes

Publication date: July 2021

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)

Publication date: August 2020

MDCG 2019-13: Guidance on sampling of devices for the assessment of the technical documentation

Publication date: December 2019

MDCG 2018-8: Guidance on content of the certificates, voluntary certificate transfers

Publication date: November 2018

NBOG BPG 2017-2: Best practice guidance on the information required for personnel involved in conformity assessment

Publication date: February 2018

NBOG F 2017-8: Review of qualification for the authorisation of personnel (IVDR)

Publication date: February 2018

NBOG F 2017-6: Preliminary assessment review template (IVDR)

Publication date: February 2018

COVID-19

MDCG 2021-21: Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices

Publication date: February 2022

MDCG 2022-1: Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices

Publication date: January 2022

MDCG 2021-7: Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices

Publication date: May 2021

MDCG 2021-2: Guidance on state of the art of COVID-19 rapid antibody tests

Publication date: March 2021

COVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19

Publication date: February 2021

Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context

Publication date: April 2020