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 in vitro diagnostic medical devices Regulations from the perspectives of key stakeholders.
Read the news announcement published by DG Health and Food Safety on 8 May 2026.
Every year the Commission collects data to monitor how the Directive 2011/24/EU on cross-border health is being implemented in the EU. EU citizens have the right to receive healthcare in other EU Member States, and...
The cross-border health care directive (Directive 2011/24/EC) requires the Commission to periodically report on the operation of the Directive to the European Parliament and to the Council. The data used to analyse the operation of...
This webinar aimed to highlight the central role of the health workforce in transforming health systems, steering reforms in the way healthcare is delivered, and to showcase how EU-supported actions contribute to stronger, more evidence-based...
The EU Health Technology Assessment Regulation (HTAR) addresses some main issues in how Europe evaluates and provides access to new health technologies such as medicines, medical devices and diagnostic tools – including the fragmentation, inefficiency...
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...
The Pharmaceutical Committee meeting was organised in hybrid format and was attended by representatives from the Commission, 24 EU Member States, Iceland and the European Medicines Agency (EMA). Read the news announcement published by DG Health...
The 19th meeting of the Member State Coordination Group on Health Technology Assessment (HTACG) set up by Regulation (EU) 2021/2282 was held on 30 April 2026 online. Read the news announcement published by DG Health...
The 18th meeting of the Member State Coordination Group on Health Technology Assessment established by Regulation (EU) 2021/2282 was held on 12 February 2026 in Brussels. Representatives from all Member States joined the meeting, as...
