The European Commission offers a series of 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.
The website of the European Commission provides information on the national requirements for IVD performance studies and the pilot coordinated assessment.
An overview of the most relevant guidance documents for IVD performance studies is provided below:
| MDCG 2025-5 | Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 |
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| MDCG 2024-11 | Guidance on qualification of in vitro diagnostic medical devices |
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| MDCG 2024-4 | Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 |
| 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 | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 |
| MDCG 2023-1 | Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 |
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| Manual on Borderline |
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v1 Background note on the use of the Manual on borderline and classification for medical devices under the Directives. |
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| 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 |