The documents present a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonised implementation of the legislation. Read the news published by DG Health and...
In certain circumstances, a medical device or in vitro diagnostic medical device may be described as a breakthrough device when it represents an innovation that is expected, based on available information, to offer a novel...
This guidance is applicable to all medical devices and in vitro diagnostic medical devices. The main objectives of this guidance are to describe: the post-market surveillance (PMS) system and the PMS plan, the main activities...
The introduction of the Unique Device Identification (UDI) system referred to in Article 27 of Regulation (EU) 2017/745 on medical devices (MDR)1 aims to ensure an adequate level of identification and traceability with respect to...
This Medical Devices Coordination Group position paper aims at clarifying the timelines of the implementation of the Master UDI-DI to the abovementioned devices, as established in the respective Delegated Regulations, and the obligation to label...
This guidance aims to describe the obligations of app platform providers and their respective responsibilities under the Medical Devices Regulation/In Vitre Diagnostic medical devices Regulation as well as the Digital Services Act, which introduces requirements...
This document, which primarily targets Medical Device Software (MDSW) manufacturers, provides guidance on: the criteria for the qualification of software falling within the scope of the Medical Device Regulations, including Medical Device Artificial Intelligence, the...
This document is intended for sponsors of performance studies of in vitro diagnostic medical devices conducted within the scope of the Regulation (EU) 2017/746. It also contains information of relevance to manufacturers providing in vitro...
This document provides a first set of answers to the most frequently asked questions related to the joint application of the Artificial Intelligence Act and the Medical Devices Regulation or In vitro Diagnostic Medical Devices...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as...
