Two new delegated acts under the EU Medical Device Regulation (MDR)—C (2026) 1798 and C (2026) 1809—have been adopted, introducing important updates for manufacturers of certain categories of medical devices. Both acts focus on well-established technologies (WET): devices that are widely recognised as safe and effective due to their simple, stable design, long-standing clinical use, … Read more
The EU Commission has updated the current state of MDR/IVDR applications with the notified bodies. This new update is concerning a period ending in October 2025. The results have been documented in a .pdf power point which is split up into 4 sections: MDR Statistics The MDR survey results concerning a period ending on October … Read more
The EU Medical Device Regulation (MDR) introduced the Unique Device Identification (UDI) system to improve the identification and traceability of medical devices. Manufacturers must assign UDI codes (Basic UDI-DI, UDI-DI, and UDI-PI) to most devices before placing them on the market and register key identifiers in the EUDAMED database. For highly individualised devices, such as … Read more
The EU Commission has announced the date which the new MIR Form Template will be made mandatory. The date has been set for 1st May 2026, after which, the old MIR form template will not be accepted by competent authorities and notified bodies. To offer some background to this update, the European Commission has released … Read more
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on proposals to introduce indefinite recognition of CE-marked medical devices in Great Britain (GB). The initiative is intended to safeguard patient access and ensure the continued supply of safe and effective medical technologies. Approximately 90% of medical devices currently used in GB … Read more
Team-NB has published a new guidance document outlining harmonised Notified Body expectations for demonstrating the safety and performance of reagent devices intended for use in combination with other devices, equipment, or instruments. The document clarifies key considerations for ensuring compliance with Regulation (EU) 2017/746 (IVDR). It is intended to support and complement the existing Team-NB … Read more
Team-NB has released a position paper addressing the European Commission’s proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The paper acknowledges that the proposed changes present opportunities to enhance predictability, transparency, and efficiency within the conformity assessment process. Notified Bodies (NBs) broadly support these objectives and recognise that the … Read more
Earlier this month, we had the pleasure of exhibiting our services at WHX Dubai (formerly Arab Health). The event provided an excellent platform to connect with a wide range of medical device manufacturers from around the world who are seeking CE Marking for their products and access to the European Union market. The exhibition also … Read more
Commission Implementing Decision (EU) 2026/193 has been published, introducing a total of 12 new harmonised standards. These standards span a broad range of areas, including neurosurgical implants, sterilisation of healthcare products, and the biological evaluation of breathing gas pathways used in healthcare applications. The full list of harmonised standards can be seen listed below; Compliance … 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
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