Regulation (EU) 2017/746 (IVDR): practical implementation of annex I in pathology
Andy Kahles1, Hannah Goldschmid2, Anna-Lena Volckmar2
1Institute of Pathology, University Hospital Heidelberg, Im Neuenheimer Feld 224, 69120, Heidelberg, Germany. andy.kahles@med.uni-heidelberg.de.
Insights
Pathology departments must implement in-house in vitro diagnostic medical devices (IH-IVDs) according to the In Vitro Diagnostic Medical Devices Regulation (IVDR) safety requirements. This article details practical IH-IVD implementation at Heidelberg University Hospital to aid other institutions.
Area of Science:
- Medical Device Regulation
- In Vitro Diagnostics
- Pathology Department Operations
Background:
- The In Vitro Diagnostic Medical Devices Regulation (IVDR) sets conditions for in-house in vitro diagnostic medical devices (IH-IVDs).
- Full implementation of all IH-IVD requirements is phased, with essential safety and performance conformity mandated from May 2022.
- Article 5(5) of the IVDR outlines specific requirements for healthcare institutions.
Purpose of the Study:
- To present the practical implementation of current IH-IVD conditions at the Institute of Pathology, University Hospital of Heidelberg.
- To offer practical guidance and assistance to other institutions navigating IH-IVD requirements.
- To share experiences in adapting to the IVDR framework for in-house diagnostics.
Main Methods:
- Document review of IVDR requirements and relevant guidance.
- Analysis of IH-IVD implementation strategies at a university hospital pathology department.
- Case study approach focusing on practical application and challenges.
Main Results:
- Successful adaptation of essential safety and performance requirements for IH-IVDs.
- Development of guidance documents and handouts to support implementation.
- Identification of key challenges including personnel and time resource allocation.
Conclusions:
- Guidance documents and academic network exchange are crucial for harmonizing IVDR implementation.
- Ensuring IVDR conformity presents significant personnel and time challenges for institutions.
- Balancing IVDR compliance with patient care, teaching, research, and quality management is essential.
Background:
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) imposes several conditions on pathology departments that develop and use in-house in vitro diagnostic medical devices (IH-IVDs). However, not all of these conditions need to be implemented immediately after the IVDR entered into force on 26 May 2022. Based on an amending regulation of the European Parliament and the Council of the European Union, the requirements for IH-IVDs will be phased in. Conformity with the essential safety and performance requirements of annex I must be ensured from May 2022.
Objectives:
With this article, we would like to present the practical implementation of the currently valid conditions for IH-IVDs at the Institute of Pathology at the University Hospital of Heidelberg, in order to provide possible assistance to other institutions.
Conclusions:
In addition to the intensive work on the requirements for IH-IVDs, several guidance documents and handouts provide orientation for the implementation and harmonisation of the requirements for healthcare institutions mentioned in Article 5 (5). Exchange in academic network structures is also of great importance for the interpretation and practical implementation of the IVDR. For university and nonuniversity institutions, ensuring conformity with the IVDR represents a further challenge in terms of personnel and time, in addition to the essential tasks of patient care, teaching and research and the further development of methods for optimal and targeted diagnostics, as well as the maintenance of the constantly evolving quality management system.
