The European Commission has launched a new Call for Evidence as part of a targeted initiative to streamline the EU regulatory framework for medical devices—without conducting a full impact assessment. This step builds on ongoing evaluations of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). … Read more
The MDCG guidance document 2024-14 has recently been updated to reflect regulatory changes. This document provides clarification on the application of the Master UDI-DI for contact lenses under the EU Medical Devices Regulation (MDR). To offer some background to this document, the Unique Device Identification (UDI) system, as outlined in Article 27 of Regulation (EU) … Read more
The EU Commission has updated the MDR Language Requirements Table. To offer some background to this update, the document, initially released in January of 2024, was published to aid manufacturers navigate the language requirements of different member states. The table is very well organised and is segmented per EU Member states making reference to the … Read more
The Maltese Medicines Authority (MMA), in collaboration with other EU competent authorities, has introduced additional mandatory national measures to increase transparency of medical device and in vitro medical device registrations. New Mandatory Requirements: All medical devices including in vitro medical devices, regardless of classification must be registered with the competent authority by the authorised representative … Read more
In July 2023, the European Commission introduced Commission Delegated Regulation 2023/2197, establishing specific rules for assigning Unique Device Identifiers (UDI) to contact lenses. This regulation not only outlined tailored requirements for UDI-DI assignment but also provided manufacturers with an extended timeline to comply. Commission Delegated Regulation 2025/788 has now updated these provisions. While the original … Read more
The MDCG has released a position paper regarding the timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles. To offer some background to this position paper, the introduction of the Unique Device Identification (UDI) system, outlined in Article 27 of Regulation (EU) 2017/745 on medical … 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 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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