The Manual on Borderline and Classifications has recently been updated. To offer some background, this document, initially published in 2022, intends to aid manufacturers determine whether a borderline product qualifies as a medical device or an in vitro diagnostic medical device (IVD) and how it should be classified by risk. The recent update sees the … Read more
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
Since the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) came into effect, the administrative workload for IVD manufacturers has increased significantly. Under the IVDR, Notified Bodies are required to review the technical documentation for Class B and Class C IVDs (used by laboratory professionals) through sampling during the validity of their certificates. Currently, … 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
We are proud to announce that Advena Malta has successfully passed the ISO 13485 Re-Certification audit with no non-conformities. This significant achievement underscores our commitment to maintaining the highest standards for our clients within the medical device industry. We remain focused on continuous improvement and will continue to prioritise the service we offer to our … Read more
As Advena Ltd in Malta continues to grow, we are now looking to recruit an experienced Business Administrator to join our team of regulatory specialists on a full-time basis. The successful candidate will work alongside our existing team of regulatory specialists, primarily on the review and preparation of various types of documentation for submission with the Maltese … 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
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