Manufacturers of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR) must be aware of a fast-approaching regulatory milestone. In accordance with (EU) 2024/1860, in order to benefit from the extended IVDR transition periods, manufacturers must satisfy a number of criteria, two of which will be due at the end of May. These … Read more
Several critical regulatory deadlines are approaching in May 2025 that manufacturers of medical devices and in vitro diagnostic devices (IVDs) should be aware of: UDI Labelling Requirement By 26 May 2025, manufacturers of Class I (MDR) and Class B & Class C (IVDR) devices must ensure that the UDI carrier is affixed to the device … Read more
We are pleased to announce that Advena will be attending Hospitalar in São Paulo from 20th to 23rd May. This marks our second visit to Latin America, and we are looking forward to reconnecting with our valued clients, as well as engaging with new prospective partners during this prominent medical trade fair. Representing Advena at … Read more
Starting from 10 January 2025, Regulation (EU) 2024/1860 introduces new requirements under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), mandating that medical device manufacturers provide information in cases of supply disruptions or product discontinuation. To comply, companies must implement structured internal processes to manage these obligations effectively. To assist … Read more
This collaborative discussion paper builds upon MedTech Europe’s 2023 position paper and presents a unified perspective from the European medical technology industry, represented by MedTech Europe, AESGP, COCIR, EEAR, EUROM, and FIDE. It advocates for a reform in the governance of the European regulatory system for medical technologies. The document underscores the need to establish … Read more
Vigilance reports are a critical component of the post-market surveillance (PMS) system established by the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) to ensure medical device safety. Manufacturers are required to systematically collect, analyse, and review real-world data on devices placed on the EU market. … Read more
The latest amendment to ISO 15223-1:2021 (Amd 1:2025) has been published, introducing crucial updates to enhance global compliance, clarity, and consistency in medical device labelling. As regulatory requirements evolve, these changes are essential for manufacturers, authorised representatives, and other stakeholders to ensure seamless international acceptance of their products. The key updates include: The updated standard … Read more
The guidance document MDCG 2020-16 has been recently updated. To offer some background to this guidance document, originally published in 2020, this guidance document provides clarification on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR), focusing on Annex VIII classification rules. It applies to diagnostic services performed on EU … Read more
We had a fantastic time at Medical Fair India this year! It was an incredible opportunity to meet so many of our valued clients and connect with prospective new clients in the medical device industry. We always appreciate the chance to engage with manufacturers looking to bring their medical devices to the European market. The … Read more
The EU Commission has published the draft regulation regarding the assignment of Unique Device Identifiers for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. The aim of this regulation is to resolve the implementation issue concerning the registration of UDI-DI data elements in EUDAMED for the mentioned devices, similar to what was done for contact … Read more
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