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MDR

Concept of MDR Medical Device Regulation.

UPDATE: Q&A on the Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices and In Vitro Diagnostic Devices.

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The European Commission has updated its Q&A on the information obligations related to the interruption or discontinuation of supply of certain medical devices and in vitro diagnostic devices (IVDs). By way of background, Regulation (EU) 2024/1860—adopted in 2024—introduced several amendments aimed at strengthening patient safety and improving regulatory efficiency. Key developments include the gradual roll-out … Read more

Concept of MDR Medical Device Regulation.

COMMISSION IMPLEMENTING DECISION (EU) 2026/760

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The European Commission has published Implementing Decision (EU) 2026/760, further updating the list of harmonized standards supporting compliance with the Medical Devices Regulation (EU) 2017/745 (MDR). In particular, the Decision adds three new harmonized standards: Implementing Decision (EU) 2026/760 can be accessed using the following link

Concept of MDR Medical Device Regulation.

ISO 20417:2026 Published: Key Updates to Medical Device Labelling and Information Requirements

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ISO 20417:2026 has been published, setting out updated general requirements for the information to be supplied by manufacturers of medical devices and their accessories. The standard covers key elements such as device identification, labelling, packaging information, marking, and accompanying documentation, including instructions for use. ISO 20417 continues to serve as a foundational framework, establishing common … Read more

Concept of MDR Medical Device Regulation.

New Delegated Acts under the MDR Introduce Targeted Relief for Well-Established Technologies

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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, … Read more

Concept of MDR Medical Device Regulation.

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

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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 … Read more

Concept of MDR Medical Device Regulation.

Team NB Publish Position Paper on MDR/IVDR Revision

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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 … Read more

Concept of MDR Medical Device Regulation.

COMMISSION IMPLEMENTING DECISION (EU) 2026/193

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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 … Read more

Concept of MDR Medical Device Regulation.

New Notified Body has been Designated Under the MDR

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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 … Read more

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