Scope of new regulation on in vitro diagnostic medical devices

被引：0
|
作者：
Hernandez, G. H. [1 ]
机构：
[1] Agencia Espanola Medicamentos & Prod Sanitarios A, Notified Body 0318, Madrid, Spain
来源：
ANNALS OF NUTRITION AND METABOLISM | 2022年 / 78卷 / SUPPL 3期
关键词：
D O I：
暂无
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
PL09
引用
收藏
页码：7 / 7
页数：1
相关论文
共 50 条
  • [21] Performance evaluation of in vitro diagnostic medical devices: Methodology and differences compared to studies on other medical devices
    Grifa, Rosa Anna
    Pozzoli, Giacomo
    [J]. MICROCHEMICAL JOURNAL, 2018, 136 : 279 - 282
  • [22] The Impact of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 on Gene Therapy Medicinal Product Developers
    Marasco, Claire
    Ruiz, Juan
    Shay, Ashley
    Shilling, Christopher J.
    [J]. MOLECULAR THERAPY, 2023, 31 (04) : 482 - 482
  • [23] Finding our way in the In Vitro Diagnostic Medical Devices Regulation: a discussion paper from the European Bioanalysis Forum
    Timmerman, Philip
    Lauren, Anna
    Nelson, Robert
    Barfield, Matthew
    [J]. BIOANALYSIS, 2024, 16 (03) : 117 - 120
  • [24] Implementing Regulation (EU) 2017/746 of 5 April 2017 on In vitro Diagnostic Medical Devices (IVDR) in Medical Laboratories, especially in Ophthalmopathology
    Auw-Hadrich, Claudia
    Reinhard, Thomas
    Hadrich, Johannes
    [J]. KLINISCHE MONATSBLATTER FUR AUGENHEILKUNDE, 2022, 239 (07) : 905 - 912
  • [25] Importance of reporting adverse incidents relating to in vitro diagnostic medical devices
    Glasspool, M
    [J]. CYTOPATHOLOGY, 1997, 8 (03) : 218 - 218
  • [26] A new regulation for substance-based medical devices
    Buxeraud, Jacques
    Faure, Sebastien
    Guerriaud, Mathieu
    Eskenazy, Deborah
    Sergheraert, Laurence
    Des Varannes, Stanislas Bruley
    [J]. ACTUALITES PHARMACEUTIQUES, 2021, 60 (602): : 48 - 53
  • [27] Regulation and safe adoption of new medical devices and procedures
    Campbell, Bruce
    [J]. BRITISH MEDICAL BULLETIN, 2013, 107 (01) : 5 - 18
  • [28] New European Regulation for Medical Devices: What Is Changing?
    Nicolas Martelli
    Déborah Eskenazy
    Carole Déan
    Judith Pineau
    Patrice Prognon
    Gilles Chatellier
    Marc Sapoval
    Olivier Pellerin
    [J]. CardioVascular and Interventional Radiology, 2019, 42 : 1272 - 1278
  • [29] New European Regulation for Medical Devices: What Is Changing?
    Martelli, Nicolas
    Eskenazy, Deborah
    Dean, Carole
    Pineau, Judith
    Prognon, Patrice
    Chatellier, Gilles
    Sapoval, Marc
    Pellerin, Olivier
    [J]. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 2019, 42 (09) : 1272 - 1278
  • [30] New regulation of medical devices in the EU: impact in dermatology
    Malvehy, J.
    Ginsberg, R.
    Sampietro-Colom, L.
    Ficapal, J.
    Combalia, M.
    Svedenhag, P.
    [J]. JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2022, 36 (03) : 360 - 364
12345