Structure and content of the EU-IVDR : Current status and implications for pathology.

BACKGROUND: Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was passed by the European Parliament and the Council of the European Union on 5 April 2017 and came into force on 26 May 2017. A new amending regulation, which introduces a phased implementation of the IVDR with new transitional provisions for certain in vitro diagnostic medical devices (IVDs) and a later date of application of some requirements for in-house devices for healthcare facilities, was adopted on 15 December 2021. The combined use of CE-certified IVDs (CE-IVDs), in-house IVDs (IH-IVDs), and research use only (RUO) devices are a cornerstone of diagnostics in pathology departments and crucial for optimal patient care. The IVDR not only regulates the manufacture and placement on the market of industrially manufactured IVDs, but also imposes conditions on the manufacture and use of IH-IVDs for internal use by healthcare facilities. OBJECTIVES: Our work provides an overview of the background and structure of the IVDR and identifies core areas that need to be interpreted and fleshed out in the context of the legal framework as well as expert knowledge. CONCLUSIONS: The gaps and ambiguities in the IVDR crucially require the expertise of professional societies, alliances, and individual stakeholders to successfully facilitate the implementation and use of the IVDR in pathology departments and to avoid aberrant developments.

[Structure and content of the EU-IVDR : Current status and implications for pathology]. / Struktur und Inhalt der EU-IVDR : Bestandsaufnahme und Implikationen für die Pathologie.

BACKGROUND: Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was passed by the European Parliament and the Council of the European Union on 5 April 2017 and came into force on 26 May 2017. A new amending regulation, which introduces a phased implementation of the IVDR with new transitional provisions for certain in vitro diagnostic medical devices and a later date of application of some requirements for in-house devices for healthcare facilities, was adopted on 15 December 2021. The combined use of CE-IVDs, in-house IVDs, and RUO products are a cornerstone of diagnostics in pathology departments and crucial for optimal patient care. The IVDR not only regulates the manufacture and placement on the market of industrially manufactured IVDs, but also imposes conditions on the manufacture and use of IH-IVDs for internal use by healthcare facilities. OBJECTIVES: Our work provides an overview of the background and structure of the IVDR and identifies core areas that need to be interpreted and fleshed out in the context of the legal framework as well as expert knowledge. CONCLUSIONS: The gaps and ambiguities in the IVDR crucially require the expertise of professional societies, alliances, and individual stakeholders to successfully facilitate the implementation and use of the IVDR in pathology departments and to avoid aberrant developments.

Individualized medicine and demographic change as determining workload factors in pathology: quo vadis?

The advent of individualized medicine with novel guidelines, extended quality assessment as well as intensified conventional, immunohistochemical, and molecular characterization of diseases has led to a substantial increase of pathologists' workload. Furthermore, in industrialized countries, we are facing the challenges of demographic change with an aging population. This raises the question of how pathology will be affected by these developments in the future. We extracted German population data and data on the number of board-certified physicians and pathologists from official sources. These data were reviewed in the light of data on caseload, case complexity, auxiliary diagnostic procedures, and matching patient data from a large German pathology department serving as a sector independent regional service provider. The refinement of diagnostic procedures over the last decade has resulted in a 60 % increase in slide numbers per case, doubling of immunohistochemistry procedures, and more than tripling of molecular analyses. Correlation of this development to demographics suggests that an aging population will further increase the caseload and case complexity in the coming decades since patient age is tightly linked to both parameters. This development is currently not accompanied by a sufficient increase in the number of pathologists. Our data point toward an imbalance between the increase in pathology workload and the number of pathologists. Extrapolations suggest a further aggravation of this development in the future. Thus, healthcare systems need to address this problem urgently in order to cope with these challenges.