The aim of this study is to support monitoring and analyzing the availability of medical devices on the EU market in the context of the implementation of medical devices and in vitro diagnostic medical devices...
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 proposal for a regulation is a response to requests from the European Parliament, several Member States and numerous stakeholders for a simplification of the regulatory framework for medical devices and for measures to ensure...
In view of the challenges encountered in transitioning to the new requirements and to respond to the calls for urgent action from the European Parliament, the Council and a large number of stakeholders, the Commission...
This evaluation covers the period between the adoption of the legislation (5 April 2017) and 31 December 2024. It covers both the basic acts as well as implementing and delegated acts adopted during this timeframe....
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 seventeenth meeting of the Member State Coordination Group on Health Technology Assessment set up by Regulation (EU) 2021/2282 was held on 28 November 2025 in Brussels. Read the news announcement published by EC Directorate-General for...
This webinar explained the process for joint clinical assessments and joint scientific consultations for high-risk medical devices and in vitro diagnostic medical devices, and the European Commission demonstrated the HTA IT Platform which is used...
The Industry Standing Group (ISG) is a forum for interaction that has been established as part of the EMA’s continuous improvement for engagement with industry stakeholders supply chain of human, veterinary and medical device sectors...
The Industry Standing Group (ISG) is a forum for interaction that has been established as part of the EMA’s continuous improvement for engagement with industry stakeholders supply chain of human, veterinary and medical device sectors...
