Europese guidance-documenten
De Europese Commissie biedt een reeks guidance-documenten aan om belanghebbenden te helpen bij de uitvoering van de IVDR en de MDR.
De guidance-documenten zijn bekrachtigd door de Medical Device Coordination Group (MDCG) en streven naar een uniforme toepassing van de MDR en de IVDR binnen de EU. Deze documenten zijn te vinden op: Guidance - MDCG endorsed documents and other guidance.
Een overzicht van de meest relevante guidance-documenten voor IVD-prestatiestudies vindt u hieronder.
| 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 |