Journal of Pathology Informatics Journal of Pathology Informatics
Contact us | Home | Login   |  Users Online: 1444  Print this pageEmail this pageSmall font sizeDefault font sizeIncrease font size 


EDITORIAL
Year : 2019  |  Volume : 10  |  Issue : 1  |  Page : 2

New European union regulations related to whole slide image scanners and image analysis software


1 Department of Pathology, Puerta del Mar Universitary Hospital, Cádiz, Spain
2 Department of ICT, Andalusian Public Health Service, Seville, Spain
3 VISILAB, Superior Engineering School, Castilla-La Mancha University, Ciudad Real, Spain

Correspondence Address:
Dr. Marcial Garcia-Rojo
Department of Pathology, Puerta del Mar Universitary Hospital, Avenida Ana de Viya, 21, 11009 Cádiz
Spain
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jpi.jpi_33_18

Rights and Permissions

Whole slide imaging (WSI) scanners and automatic image analysis algorithms, in order to be used for clinical applications, including primary diagnosis in pathology, are subject to specific regulatory frameworks in each country. Until May 25, 2018, in the European Union (EU), in vitro diagnostic (IVD) medical devices were regulated by directive 98/79/EC (in vitro diagnostic medical device directive [IVDD]). Main scanner vendors have obtained a Conformité Européenne mark of their products that in Europe were classified as General Class IVDD, so that conformity is only based on a self-declaration of the manufacturer. This contrasts with the initial classification of the US Food and Drug Administration (FDA) of WSI system as Class III medical devices, although the first digital pathology WSI system to be cleared by FDA was classified as Class II, with special controls. Other digital pathology solutions (automated cervical cytology slide reader) are considered of higher risk by US and European regulations. There is also some disparity in the classification of image analysis solutions between Europe and the United States. All IVD-MDs must be approved under the new European regulation (in vitro diagnostic medical device regulation) 2017/746 after May 26, 2024. This means the need of a performance evaluation, including a scientific validity report, an analytical performance report, and a clinical performance report. According to its clinical use (e.g., screening, diagnosis, or staging of cancer), a WSI slide scanner can be now classified as Class C device. A special regulation is applied to companion diagnostics. The new EU regulation 2017/746 contemplates the use of standard unique identifiers for medical devices and the creation of a European database on medical devices (Eudamed). Existing validation studies and clinical guidelines already available in the literature are a sound basis to avoid that this new regulation becomes a barrier for digital pathology development in Europe.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed1570    
    Printed10    
    Emailed0    
    PDF Downloaded171    
    Comments [Add]    

Recommend this journal