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
The European Commission has released an updated version of the Manufacturer Incident Report (MIR) form (Version 7.3.1), which was previously last revised in 2019. This form serves as a standardized template that manufacturers can use to report incidents involving medical devices to the relevant competent authorities. The New MIR form becomes mandatory as from November … Read more
There has been a new notified body that has been designated under the IVDR. The notified body is from Norway. The details of this notified bodies can be seen below: More information about this notified body can be found using the following link
We are pleased to announce that Advena will be attending WHX Kuala Lumpur, formally known as Asia Health from 16th to 18th July. This marks our third visit to Southeast Asia, and we are looking forward to reconnecting with our valued clients in the region, as well as engaging with new prospective partners during this … Read more
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