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
The EU Commission has released a Q&A document regarding the Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices or In-Vitro Diagnostic Devices, a measure first introduced in the amendment (EU) 2024/1860. To offer some background to this document, earlier this year, an amendment to the IVDR and MDR, dubbed … Read more
The EU Parliament has adopted a resolution to revise the MDR and IVDR to address the ongoing challenges regarding implementation and support patient access to essential medical devices by 2025. The EU Parliament’s proposed amendments to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are timely, balancing much-needed reform with a commitment … Read more
The EU Commission has released a report from a study that they have conducted concerning the reprocessing and reuse of single-use-devices in the EU. The study aimed to evaluate how the provisions that have been established in Article 17 of the MDR, which regulates the reprocessing of Single Use Devices (SUD’s), have been implemented and … Read more
On March 8th 2024 the EU Commission published in the Official Journal of the European Union (OJEU) two Commission implementing decisions concerning new references of harmonised standards in support of Regulation (EU) 2017/745 on medical devices (MDR) and of Regulation (EU) 2017/746 (IVDR). For the MDR: Commission Implementing Decision (EU) 2024/815 of 6 March 2024, … Read more
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