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MDR

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

Concept of MDR Medical Device Regulation.

Key MDR/IVDR Compliance Deadlines: May 2026

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As the EU regulatory framework for medical devices and in vitro diagnostic devices continues to mature, May 2026 marks a critical milestone for manufacturers operating under the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Several high-priority deadlines will take effect during this month, requiring immediate attention to ensure ongoing … Read more

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Video News Summary – April

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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 April, please click on video below.

Concept of MDR Medical Device Regulation.

UPDATE: MDCG 2021-24 Rev.1 Guidance on classification of medical devices

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Medical device classification in the EU follows a risk-based approach, considering factors such as invasiveness, duration of contact, and potential impact on the body. These criteria, set out in Annex VIII of the MDR, guide manufacturers in assigning the correct class, which in turn determines the level of regulatory scrutiny and conformity assessment required. The … Read more

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

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