Your browser doesn't support javascript.
loading
The gaps between the new EU legislation on in vitro diagnostics and the on-the-ground reality.
Horgan, Denis; Plebani, Mario; Orth, Matthias; Macintyre, Elizabeth; Jackson, Stan; Lal, Jonathan A; Dube, France; Kozaric, Marta; Tumiene, Birute; Salgado, Roberto; Schalken, Jack A; Capoluongo, Ettore D; Carnielli, Marta.
Afiliação
  • Horgan D; European Alliance for Personalised Medicine, Brussels, Belgium.
  • Plebani M; Department of Molecular and Cellular Engineering, Faculty of Engineering and Technology, Jacob Institute of Biotechnology and Bioengineering, Sam Higginbottom University of Agriculture, Technology and Sciences, Prayagraj, India.
  • Orth M; Dept of Laboratory Medicine, University Hospital - Padova, University of Padova, Padova, Italy.
  • Macintyre E; Institute for Laboratory Medicine, Marienhospital Stuttgart, Stuttgart, Germany.
  • Jackson S; European Hematology Association Executive Office, The Hague, The Netherlands.
  • Lal JA; Hematology, Université Paris Cité and Necker Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
  • Dube F; Astellas Pharma, Europe Ltd, Addlestone, UK.
  • Kozaric M; Department of Molecular and Cellular Engineering, Faculty of Engineering and Technology, Jacob Institute of Biotechnology and Bioengineering, Sam Higginbottom University of Agriculture, Technology and Sciences, Prayagraj, India.
  • Tumiene B; Department of Genetics and Cell Biology, GROW School of Oncology and Developmental Biology, Faculty of Health, Medicine and Life Sciences, Institute for Public Health Genomics, Maastricht University, Maastricht, The Netherlands.
  • Salgado R; Astra Zeneca, Concord Pike, Wilmington, USA.
  • Schalken JA; European Alliance for Personalised Medicine, Brussels, Belgium.
  • Capoluongo ED; Vilnius University Hospital Santaros Clinics, Vilnius, Litva.
  • Carnielli M; Department of Pathology, GZA/ZNA Hospitals, Antwerp, Belgium.
Clin Chem Lab Med ; 61(2): 224-233, 2023 01 27.
Article em En | MEDLINE | ID: mdl-36409605
The background to this debate is now well-known: an EU policy decision to tighten controls on the devices and diagnostics sector led to the adoption of a regulation in 2017 with a schedule for implementation over coming years - a timetable extended still further by last-minute legislation in early 2022, to provide the sector and regulators with more time to adapt to the changes. Discussions among experts organised in April by the European Alliance for Personalized Medicine (EAPM) exposed continuing challenges that cannot be fully resolved by the recent deferral of implementation deadlines. One salient problem is that there is little awareness of the In Vitro Diagnostic Regulation (IVDR) across Europe, and only limited awareness of the different structures of national systems involved in implementing IVDR, with consequent risks for patient and consumer access to in vitro diagnostics (IVDs). The tentative conclusion from these consultations is that despite a will across the sector to seek workable solutions, the obstacles remain formidable, and the potential solutions so far proposed remain more a matter of aspirations than of clear pathways.
Assuntos
Palavras-chave

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Medicina de Precisão Tipo de estudo: Diagnostic_studies Limite: Humans País como assunto: Europa Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Medicina de Precisão Tipo de estudo: Diagnostic_studies Limite: Humans País como assunto: Europa Idioma: En Ano de publicação: 2023 Tipo de documento: Article