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MDR

Concept of MDR Medical Device Regulation.

ISO 10993-3:2026 Published: Updated Requirements for Biological Evaluation of Medical Devices

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ISO 10993-3:2026 was officially published in August 2026 as the fourth edition of the standard. The updated standard addresses the biological evaluation of medical devices with respect to genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity. ISO 10993-3 provides manufacturers with strategies for evaluating these potential biological risks where they have been identified as relevant to … Read more

Concept of MDR Medical Device Regulation.

New Consolidated Version of MDR Published

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A new consolidated version of the MDR has recently been published. The new version incorporates the following delegated regulations: The new consolidated version of the MDR can be accessed using the following link

Concept of MDR Medical Device Regulation.

Delegated acts on well-established technologies published

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The European Commission has published two delegated acts in the Official Journal of the European Union (OJEU) introducing additional well-established technologies (WET) under the Medical Devices Regulation (MDR). Well-established technologies are generally considered to be relatively simple medical devices with stable and widely accepted designs, well-documented safety and clinical performance, and a long history of … Read more

Concept of MDR Medical Device Regulation.

MDCG 2026-5 MDCG Position Paper: UDI Assignment Between Manufacturers and Distributors

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The Medical Device Coordination Group (MDCG) has published a new position paper addressing the assignment of Unique Device Identifiers (UDIs) between manufacturers and distributors. The position paper was issued in response to a common practice whereby distributors assign their own Basic UDI-DIs and UDI-DIs under their own brand name and obtain these identifiers directly from … Read more

Concept of MDR Medical Device Regulation.

MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices Appendix: Transition to the ‘EU REP’ symbol in EN ISO 15223-1 June 2026

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The MDCG has updated the guidance document MDCG 2021-5 to include the addition of an appendix which aims to aid manufacturers transition to the new ‘EU REP’ symbol. The European Commission has confirmed a five-year transition period for the implementation of Amendment A1:2025 to harmonised standard EN ISO 15223-1:2021, which introduces the new ‘EU REP’ … Read more

Concept of MDR Medical Device Regulation.

Commission Implementing Decision (EU) 2026/1231

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The European Commission has published Implementing Decision (EU) 2026/1231, updating the list of harmonised standards that support compliance with the Medical Devices Regulation (EU) 2017/745 (MDR). The decision incorporates a wide range of standards covering key aspects of medical device design, manufacturing, safety, and performance, including: Publication of ISO 15223-1:2025 One of the most significant … Read more

Concept of MDR Medical Device Regulation.

MDCG 2026-4 MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use

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The Medical Device Coordination Group (MDCG) has recently published a position paper addressing the management of Summaries of Safety and Clinical Performance (SSCPs) for medical devices and Summaries of Safety and Performance (SSPs) for in vitro diagnostic medical devices (IVDs) within EUDAMED once the system becomes mandatory. To better understand the significance of this position … Read more

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Video News Summary – May

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We’re pleased to announce that this edition of the newsletter as well as future editions will also be available in a video summary format, offering a convenient way to catch up on the latest regulatory updates. To watch the full video summary for the month of May, please click on video below.

Concept of MDR Medical Device Regulation.

New EU Implementing Regulation Establishes Uniform Requirements for Conformity Assessment and Notified Bodies

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The European Commission has published a new Implementing Regulation introducing uniform requirements for conformity assessment activities carried out by notified bodies under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The new rules are intended to promote greater harmonisation, predictability, and efficiency within the EU medical device regulatory framework. They … Read more

Concept of MDR Medical Device Regulation.

MedTech Europe Publishes Position Paper on MDR and IVDR Revision

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MedTech Europe has published a position paper outlining its views on the proposed revision of the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). According to MedTech Europe, the European regulatory framework for medical technologies has reached a critical stage. The organisation supports the European Commission’s efforts to streamline … Read more

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