Performance evaluations will take an integral part in the CE Marking process of in vitro diagnostic medical devices under the In Vitro Diagnostic Medical Devices Regulation (IVDR). This article outlines, which guidance documents published by the International Medical Device Regulators Forum (IMDRF) manufacturers may use already now to facilitate compliance to the IVDR.
Dramatic Impact on Manufacturers of In Vitro Diagnostic Medical Devices
At present, the regulatory discussion in Europe pretty much focuses on Regulation (EU) 2017/745 on medical devices (MDR). It seems easily forgotten that the impact of Regulation (EU) 2017/746 on in vitro medical devices (IVDR) on industry is expected to be much more dramatic.
Also, manufacturers of IVD products should do whatever they can to prepare themselves for the coming date of full application in May 2022. A point that will be especially critical against this background, is the performance evaluation. The performance evaluation refers to a process in which a manufacturer must establish the scientific validity and the analytical and clinical performance of a product wherever that is applicable.
Guidance Documents issued by the IMDRF
Although no official guidance document has been published by the European Commission, the International Medical Device Regulators Forum (IMDRF, formerly Global Harmonization Task Force – GHTF) issued the guidance documents GHTF/SG5/N6:2012 (Clinical Evidence for IVD Medical Devices), GHTF/SG5/N7:2012 (Scientific Validity Determination and Performance Evaluation) and GHTF/SG5/N8:2012 (Clinical Performance Studies for IVD Medical devices. These may be used to establish a good basis for the IVDR requirements. In this context, the IVDR also references to standard ISO 20916:2019 on clinical performance studies concerning IVD devices.
Please note: you will find the required downloads, links and more at the end of this article!
Furthermore, please note that mdi Europa has compiled a template document that may be purchased separately to support your transition process. Should you require additional information, please don’t hesitate to get in touch.
Sources: IMDRF, ISO, IVDR
Guidance documents regarding the IVDR issued by the International Medical Device Regulators Forum for download
GHTF/SG5/N6:2012 (Clinical Evidence for IVD Medical Devices) [PDF 327 KB]
GHTF/SG5/N7:2012 (Scientific Validity Determination and Performance Evaluation) [PDF 769 KB]
GHTF/SG5/N8:2012 (Clinical Performance Studies for IVD Medical devices [PDF 434 KB]