European guidance documents

The European Commission offers a series of guidance documents to assist stakeholders in implementing IVDR and MDR.

The guidance documents have been endorsed by the Medical Device Coordination Group (MDCG) and aim at a uniform application of MDR and IVDR within the EU. These documents can be found at: Guidance - MDCG endorsed documents and other guidance.

An overview of the most relevant guidance documents for IVD performance studies is provided below:

In Vitro Diagnostic medical devices (IVD)
MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746
MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746
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)
MDCG 2022-9 Summary of safety and performance template
MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
MDCG 2020-16 Rev 1 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
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
Borderline and Classification
Manual on Borderline

Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v1

Background noteĀ on the use of the Manual on borderline and classification for medical devices under the Directives.

MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
MDCG 2021-24 Guidance on classification of medical devices
Helsinki Procedure Helsinki Procedure for borderline and classification under MDR & IVDR