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MDR

Concept of MDR Medical Device Regulation.

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

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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 … Read more

Concept of MDR Medical Device Regulation.

UPDATE: MDCG 2025-7 Rev. 1 MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles

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The MDCG has recently updated a guidance document concerning the timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles. To offer some background to this document, the Unique Device Identification (UDI) system under Article 27 MDR ensures the traceability of medical devices by requiring manufacturers … Read more

Concept of MDR Medical Device Regulation.

MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices

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The MDCG has recently published a guidance concerning post-market surveillance requirements for Medical Device and IVD’s. Unless otherwise specified, this guidance applies to all medical devices (MDs) and in vitro diagnostic medical devices (IVDs). To offer some background to this guidance document, Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in … Read more

Concept of MDR Medical Device Regulation.

MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746

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The MDCG has recently published a guidance document concerning BtX, commonly known as break through devices. To offer some background to this guidance document, a medical device (MD) or in vitro diagnostic (IVD) may be designated as a breakthrough device (BtX) if it represents a significant innovation that offers a novel diagnostic or therapeutic solution … Read more

Concept of MDR Medical Device Regulation.

WHO Publish Second Edition of Development of Medical Device Policies

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The first edition of the Development of Medical Devices Policies was published in 2011. This second edition has been updated to reflect the global shift from the Millennium Development Goals to the Sustainable Development Goals, ensuring alignment with today’s health priorities. New sections have been introduced to address emerging public health challenges, including sustainability, digital … Read more

Concept of MDR Medical Device Regulation.

New Notified Body has been Designated under MDR

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There has been a new notified body that have been designated under the MDR. The new notified body: NOTICE, storitve ugotavljanja skladnosti, d.o.o. is from Slovenia. This new addition brings the total number of notified bodies under the MDR to 51. More information about this notified body can be found using the following link

Concept of MDR Medical Device Regulation.

COMMISSION IMPLEMENTING DECISION (EU) 2025/2078

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On October 17, 2025, the EU Commission published the Commission Implementing Decision (EU) 2025/2078, which amends Implementing Decision (EU) 2021/1182. This new decision confirms the adoption of harmonized standards for several categories of medical devices, specifically surgical clothing and drapes, medical face masks, and sterilizers for medical purposes. The decision outlines the following standards, which … Read more

Concept of MDR Medical Device Regulation.

MDCG Releases Draft Guidance on Trend Reporting

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The MDCG has released a draft guidance document with regard to Trend Reporting, currently numbered as MDCG 2025-XX. To provide context for this release, the draft guidance document MDCG 2025-XX has been developed to explain and clarify key aspects of Trend reporting as outlined in Article 88 of Regulation (EU) 2017/745 on medical devices (MDR) … Read more

Concept of MDR Medical Device Regulation.

UPDATE: Manual on Borderline and Classification

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The Manual on Borderline and Classifications has recently been updated. To offer some background, this document, initially published in 2022, intends to aid manufacturers determine whether a borderline product qualifies as a medical device or an in vitro diagnostic medical device (IVD) and how it should be classified by risk. The recent update sees the … Read more

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