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MDR

Concept of MDR Medical Device Regulation.

UPDATE: MDCG 2019-11 Rev.1 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

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There has been an update to the guidance document MDCG 2019-11 concerning Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. originally released in 2019, this guidance document, aimed primarily at Medical Device Software (MDSW) manufacturers, offers guidance on the following: The criteria outlined in this document … Read more

Concept of MDR Medical Device Regulation.

MDCG 2025-4: Guidance on the safe making available of medical device software (MDSW) apps on online platforms

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The MDCG has released a new guidance relating to safe making available of medical device software (MDSW) apps on online platforms. To offer some background to this guidance, Software Applications (Apps) are transforming the way we live, playing an increasingly important role in various aspects of our daily lives, including healthcare. Among these are Medical … Read more

Concept of MDR Medical Device Regulation.

EMDN Helpdesk is Now Active

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The European Medical Device Nomenclature (EMDN) Helpdesk is now operational and ready to assist with your questions related to EMDN codes. This service, part of the SMEMDN project co-funded by the European Commission, is designed to help users navigate the EMDN structure—including categories, groups, and types—and to support manufacturers in selecting the correct EMDN code(s) … Read more

Concept of MDR Medical Device Regulation.

EU Commission Release New MIR Template

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The European Commission has released an updated version of the Manufacturer Incident Report (MIR) form (Version 7.3.1), which was previously last revised in 2019. This form serves as a standardized template that manufacturers can use to report incidents involving medical devices to the relevant competent authorities. The New MIR form becomes mandatory as from November … Read more

Concept of MDR Medical Device Regulation.

Deadline of UDI Carrier on Labelling has Arrived for Certain Devices

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By 26thMay 2025, manufacturers of certain medical devices must ensure that the UDI carrier is correctly affixed to the device, label or packaging. These include: This deadline is a critical step in the full implementation of the Unique Device Identification (UDI) system, aimed at enhancing the traceability, safety, and post-market surveillance of medical devices across … Read more

Concept of MDR Medical Device Regulation.

Important Dates for Manufacturers

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Several critical regulatory deadlines are approaching in May 2025 that manufacturers of medical devices and in vitro diagnostic devices (IVDs) should be aware of: UDI Labelling Requirement By 26 May 2025, manufacturers of Class I (MDR) and Class B & Class C (IVDR) devices must ensure that the UDI carrier is affixed to the device … Read more

Concept of MDR Medical Device Regulation.

MEDTECH Europe Issue Decision Making Flowchart Regarding Article 10a MDR/IVDR

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Starting from 10 January 2025, Regulation (EU) 2024/1860 introduces new requirements under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), mandating that medical device manufacturers provide information in cases of supply disruptions or product discontinuation. To comply, companies must implement structured internal processes to manage these obligations effectively. To assist … Read more

Concept of MDR Medical Device Regulation.

Various European Organisations Publish Joint Discussion Paper on the Future Governance of Medical Technologies in Europe

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This collaborative discussion paper builds upon MedTech Europe’s 2023 position paper and presents a unified perspective from the European medical technology industry, represented by MedTech Europe, AESGP, COCIR, EEAR, EUROM, and FIDE. It advocates for a reform in the governance of the European regulatory system for medical technologies. The document underscores the need to establish … Read more

Concept of MDR Medical Device Regulation.

MEDTECH Europe Issue Position Paper on Submission of vigilance reports to Notified Bodies under EU MDR & IVDR

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Vigilance reports are a critical component of the post-market surveillance (PMS) system established by the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) to ensure medical device safety. Manufacturers are required to systematically collect, analyse, and review real-world data on devices placed on the EU market. … Read more

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