The European Commission has released a revised timeline for the gradual rollout of the European Database on Medical Devices (EUDAMED), reflecting the current consultation status with the Medical Device Coordination Group (MDCG) and recent policy updates. This timeline clarifies key milestones for stakeholders and provides crucial visibility into when the different EUDAMED modules are expected … Read more
There has been a new notified body that have been designated under the IVDR. The new notified body: POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. is from Poland. This new addition brings the total number of notified bodies to 18. More information about this notified body can be found using the following link
We are pleased to announce that Advena will be exhibiting at United Medical Expo in October. The fair will be held on the 29th and 30th of October at the Astana Expo IEC, Astana Kazakhstan. This is the first time we will be exhibiting in Central Asia, and we are excited to see what this … Read more
As many of our readers are aware, in July we had the pleasure of attending WHX Kuala Lumpur, a leading international exhibition for the medical and healthcare industry in the ASEAN region. The event, held in Malaysia’s vibrant capital, brought together key players from across Southeast Asia’s medical device and health tech sectors. During our … Read more
The MDCG has released a guidance document concerning the interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA). This document offers an initial set of answers to the most frequently asked questions concerning the joint application of the Artificial Intelligence Act (AIA) and … Read more
There has been an update to the guidance document MDCG 2019-11 concerning Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. originally released in 2019, this guidance document, aimed primarily at Medical Device Software (MDSW) manufacturers, offers guidance on the following: The criteria outlined in this document … Read more
The MDCG has released a guidance pertaining to Q&A on performance studies relating to IVDR. To offer some background to this document, this document is intended for sponsors of performance studies involving in vitro diagnostic medical devices (IVDs) conducted under Regulation (EU) 2017/746 (IVDR). It also provides relevant information for manufacturers supplying IVDs for use … Read more
The MDCG has released a new guidance relating to safe making available of medical device software (MDSW) apps on online platforms. To offer some background to this guidance, Software Applications (Apps) are transforming the way we live, playing an increasingly important role in various aspects of our daily lives, including healthcare. Among these are Medical … Read more
The European Medical Device Nomenclature (EMDN) Helpdesk is now operational and ready to assist with your questions related to EMDN codes. This service, part of the SMEMDN project co-funded by the European Commission, is designed to help users navigate the EMDN structure—including categories, groups, and types—and to support manufacturers in selecting the correct EMDN code(s) … 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 2024. 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
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