On October 17, 2025, the EU Commission published the Commission Implementing Decision (EU) 2025/2078, which amends Implementing Decision (EU) 2021/1182. This new decision confirms the adoption of harmonized standards for several categories of medical devices, specifically surgical clothing and drapes, medical face masks, and sterilizers for medical purposes. The decision outlines the following standards, which … Read more
TEAM NB has recently updated their Position Paper “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746”. To offer some background to this document, TEAM NB has developed unified best practice guidance to clarify expectations for technical documentation submissions under the … Read more
The MDCG has released a draft guidance document with regard to Trend Reporting, currently numbered as MDCG 2025-XX. To provide context for this release, the draft guidance document MDCG 2025-XX has been developed to explain and clarify key aspects of Trend reporting as outlined in Article 88 of Regulation (EU) 2017/745 on medical devices (MDR) … Read more
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
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