New Delegated Acts under the MDR Introduce Targeted Relief for Well-Established Technologies
Two new delegated acts under the EU Medical Device Regulation (MDR)—C (2026) 1798 and C (2026) 1809—have been adopted, introducing important updates for manufacturers of certain categories of medical devices. Both acts focus on well-established technologies (WET): devices that are widely recognised as safe and effective due to their simple, stable design, long-standing clinical use, ...
UPDATE: Notified Bodies Survey on Certifications and Applications
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 2025. 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 ...
UPDATE: MDCG 2025-8 Rev. 1 Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles
The EU Medical Device Regulation (MDR) introduced the Unique Device Identification (UDI) system to improve the identification and traceability of medical devices. Manufacturers must assign UDI codes (Basic UDI-DI, UDI-DI, and UDI-PI) to most devices before placing them on the market and register key identifiers in the EUDAMED database. For highly individualised devices, such as ...
Team NB Publish Position Paper on MDR/IVDR Revision
Team-NB has released a position paper addressing the European Commission’s proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The paper acknowledges that the proposed changes present opportunities to enhance predictability, transparency, and efficiency within the conformity assessment process. Notified Bodies (NBs) broadly support these objectives and recognise that the ...
COMMISSION IMPLEMENTING DECISION (EU) 2026/193
Commission Implementing Decision (EU) 2026/193 has been published, introducing a total of 12 new harmonised standards. These standards span a broad range of areas, including neurosurgical implants, sterilisation of healthcare products, and the biological evaluation of breathing gas pathways used in healthcare applications. The full list of harmonised standards can be seen listed below; Compliance ...
New Notified Body has been Designated Under the MDR
The first Notified Body under the Medical Device Regulation (MDR) has officially opened in Malta, marking an important milestone for both the local life sciences sector and the wider European medical device landscape. In simple terms, a Notified Body (NB) designated under the Medical Device Regulation (EU) 2017/745 is an independent, third-party organisation appointed by ...
ISO 10993-1:2025 – Biological evaluation of medical devices. Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
ISO 10993-1:2025 has recently been published, introducing important updates to the cornerstone standard for the biological evaluation of medical devices. ISO 10993-1 plays a critical role in defining the principles and requirements for assessing the biological safety of medical devices within the broader risk management framework established by ISO 14971. The standard guides manufacturers and ...
Proposal for a Regulation to Simplify Rules on Medical and In Vitro Diagnostic Devices
On the 16th of December, the EU published their plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices. This proposal seeks to streamline and future-proof the EU regulatory framework for medical devices and in vitro diagnostics. Its primary objective is to simplify applicable rules, reduce administrative burdens ...
EUDAMED to Become Mandatory as from 28th May 2026
A Commission Decision entering into force on 27 November confirmed that certain electronic systems meet their required functional specifications. This decision has triggered a six-month transition period, as outlined in the Regulation governing EUDAMED’s gradual roll-out. This would mean that the following modules will become mandatory 6 months after this publication. This would make the ...
EUDAMED Training Updates and Key Implementation Timelines
Over the past few months, a member of the Advena Team has participated in several training sessions and workshops organized by the European Commission focusing on the implementation of EUDAMED — the European Database on Medical Devices. These sessions provided valuable insights into the system’s structure, functionality, and the upcoming regulatory requirements for economic operators. ...
