On 16 March, the European Commission hosted a high-level conference in Brussels entitled “Medical Devices: Innovation and patient safety”, under the auspices of the Cypriot Presidency of the Council. Participants included representatives from EU regulatory...
The second training provided an overview of the European Medical Device Nomenclature (EMDN), its structure, the consultation process, and Annex XVI. It also covered the practical application of code selection and update requests, as well...
The European Medicines Agency (EMA) is hosting a workshop on supporting innovation in cardiovascular medicines and medical devices in the EU. This multi-stakeholder workshop will cover interdisciplinary discussions addressing a range of important topics including...
The 18th meeting of the Member State Coordination Group on Health Technology Assessment (HTACG) set up by Regulation (EU) 2021/2282 was held on 12 February 2026 in Brussels. The HTACG agreed on the strategic importance...
The European Medicines Agency (EMA) is hosting a workshop on supporting innovation in cardiovascular medicines and medical devices in the EU. This multi-stakeholder workshop will cover interdisciplinary discussions addressing a range of important topics including...
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...
Harmonised standards under the Regulations on medical devices and in vitro diagnostic medical devices are developed by CEN and CENELEC as European standardisation organisations, on the basis of a standardisation request issued by the Commission...
The European Commission has today proposed an ambitious package of measures to improve the health of EU citizens, while ensuring the long-term resilience and competitiveness of the health sector. The package includes a Biotech Act, revised...
The European Commission has adopted an implementing act designating four EU reference laboratories in the field of in vitro diagnostic medical devices (IVDs). These laboratories will be involved in the conformity assessment of high-risk (class...
On behalf of the European Commission, HaDEA has signed a contract with a consortium of European companies to develop a groundbreaking diagnostic device that will provide antimicrobial susceptibility results on bacteria within an hour. This new...
