The EU Commission has recently published videos from the third EMDN Training. To offer some background to this training module, the third training provided an overview of the evolving role of the EMDN, with particular focus on its practical use throughout the device lifecycle. It covered the application of the nomenclature in regulatory activities, practical … Read more
The European Commission has recently updated its list of the standard fees charged by EU Notified Bodies. The revised list includes the fees of Notified Bodies that have been designated since the previous publication, such as Malta Conformity Assessment (MCA). The updated list provides manufacturers with a useful reference for comparing the standard fee structures … Read more
From 1 July 2026, the EU will introduce a temporary €3 customs duty on imported consignments valued at up to €150, ending the long-standing duty exemption for low-value goods. The flat-rate duty will remain in place until 1 July 2028, after which standard customs duties will apply based on the type of product. The measure … Read more
The EU Commission has updated the results of the Study Supporting the Monitoring of the Availability of Medical Devices on the EU market. This new update is concerning a period ending in December 2025. The results have been documented in a .pdf power point which is split up into 5 sections: To offer some background … Read more
In preparation for the mandatory implementation of EUDAMED, the European Commission is offering a series of training courses covering key modules. These modules will become mandatory as of 28 May 2026. We strongly encourage our clients to attend these sessions, as they provide valuable guidance on how to use EUDAMED effectively and help ensure you … Read more
The Austrian National Public Health Institute is conducting a survey on behalf of the European Commission (DG SANTE/HaDEA) to collect information and data on the status of the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/745 (IVDR). The aim of this survey is to get a realistic picture of the status of the … Read more
On the 16th of December, the EU published their plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices. This proposal seeks to streamline and future-proof the EU regulatory framework for medical devices and in vitro diagnostics. Its primary objective is to simplify applicable rules, reduce administrative burdens … Read more
The EU has recently published a guidance concerning the AI Act. The guidelines on defining AI systems clarify the practical application of the legal concept established in the AI Act. By providing these guidelines, the European Commission aims to assist providers and other relevant stakeholders in determining whether a software system qualifies as an AI … Read more
The European Commission has initiated a public consultation and call for evidence as part of a targeted evaluation of the EU legislation on medical devices and in vitro diagnostic medical devices. This consultation offers stakeholders the chance to share their views on the effectiveness of the current regulations and identify any potential shortcomings. The regulations … Read more
The European Commission has recently released a comprehensive Q&A document designed to assist manufacturers and other stakeholders in understanding the new amendment concerning the phased implementation of EUDAMED. This amendment, introduced through Regulation (EU) 2024/1860, was published in mid-June and addresses three key areas within the framework of the Medical Device Regulation (MDR) and In … Read more
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