Impact of the New European In-Vitro Diagnostics Regulation for Medical Laboratories and Related Stakeholders
June 17, 2019
The current regulatory rules governing in vitro diagnostic medical devices (IVDMD) in the European Union are mainly represented by the European IVD Directive dating back from 1998. This directive does not cover devices with characteristics related to newer techniques and applications in current in vitro diagnostic testing. It also lacks conformity with current international guidelines and regulation systems with regard to a number of regulatory elements such as risk-based classification of IVDMD, clinical evaluation, identification and labelling of IVDMD and handling of requirements for “in-house testing” (referring to devices manufactured and used within one single health facility).
The new Regulation (EU) 2017/746 (“IVDR”) will have to be fully implemented by May 2022 and aims at solving these shortcomings. It will therefore significantly change the regulatory requirements for manufacturers and other stakeholders such as notified bodies and competent authorities. It will also largely impact medical laboratories with their different roles as users of IVDMD, as manufacturers of “in-house”- IVDMD and as institutions involved in performance/clinical evaluation of new devices.
This web session will give an overview on the chances and challenges derived from the IVDR with a special focus on medical laboratories.
University of Applied Sciences, Luebeck, Germany