The Medical Device Coordination Group (MDCG) has published the following updates:
| Guidance No | About the guidance |
|---|---|
| MDCG 2022-2 | Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) This document outlines the general principles of clinical evidence and provides guidance on the continuous process of performance evaluation for in vitro diagnostic medical devices (hereafter referred to as IVDs), as set out in Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR). This guidance describes the approach by which collection, generation and documentation of supporting data for an IVD may be conducted prior to the placing on the market or putting into service. As the performance evaluation will be updated throughout the life cycle of an IVD, this document also addresses principles related to post-market surveillance, such as post-market performance follow-up. The target audience of this document is IVD manufacturers, investigators and studysponsors. This document is also intended to inform regulators, notified bodies andother stakeholders when considering clinical evidence provided by manufacturers. In order to promote global convergence, this document takes into account certain concepts outlined in the Global Harmonisation Task Force guidance documents(such as SG5/N7:2012). |
| MDCG 2022-1 | Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices This notice is addressed to manufacturers of in vitro diagnostic medical devices (IVDs) with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection1 who are based in countries outside the EU or the EEA and who place or intend to place the above mentioned devices on the EU market. It is intended to highlight a number of common issues that EU national competent authorities have identified in the course of their market surveillance activities regarding compliance of SARS-CoV-2 IVDs with the requirements of Directive 98/79/EC on in vitro diagnostic medical devices. These issues can also be relevant for SARS-CoV-2 devices which are transitioning to Regulation (EU) 2017/746 (also see last paragraph). |