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