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Concept of MDR Medical Device Regulation.

UPDATE: Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices

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The Borderline Manual on Medical Devices has recently been updated, introducing five additional product examples that fall into “grey areas” of qualification and classification. Originally published in 2022, this guidance aims to support manufacturers in determining whether a product qualifies as a medical device and how it should be classified under the MDR. 1. Device … Read more

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

EUDAMED Webinars by EU Commission

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In preparation for the mandatory implementation of EUDAMED, the European Commission is offering a series of training courses covering key modules. These modules will become mandatory as of 28 May 2026. We strongly encourage our clients to attend these sessions, as they provide valuable guidance on how to use EUDAMED effectively and help ensure you … 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

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MHRA Launches a Consultation on Indefinite Recognition of CE-marked Medical Devices 

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The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on proposals to introduce indefinite recognition of CE-marked medical devices in Great Britain (GB). The initiative is intended to safeguard patient access and ensure the continued supply of safe and effective medical technologies. Approximately 90% of medical devices currently used in GB … Read more

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