The aim of the study, commissionned by the DG SANTE, 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...
Because of their very specific use and target, orphan medical devices are often difficult to develop, with challenges in access to the market and in addressing unmet medical needs. Under the EU4Health programme, three projects support the development of orphan medical devices for paediatric...
On 5 May 2026, the Official Journal of the EU released Commission Implementing Regulation (EU) 2026/977. This Regulation lays down uniform quality management and procedural requirements for the conformity assessment activities carried out by a...
The European Commission has released a revised version of the Manufacturer Incident Report (MIR) form for serious incidents. Version 7.3.1 (build SB-11010) becomes mandatory on 1st May 2026. Read the news published by DG Health and Food...
This Q&A document is intended to facilitate the application of Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) as...
This decision tree is intended to complement the Q&A document aiming to facilitate the application of Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending the Regulations (EU)...
In the second quarter of 2026, the European Medicines Agency will launch a pilot programme to support breakthrough medical devices and in vitro diagnostics. The aim is to test a pathway that accelerates patient access...
The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. This...
This document records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG)1 following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices and Regulation...
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...
