EU Commission Release New MIR Template
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 ...
Importance of Clinical Evaluations
In the evolving landscape of medical device regulation, clinical evaluation has taken centre stage. With the introduction of the Medical Device Regulation (EU) 2017/745 (MDR), the requirements around clinical evaluations have been significantly reinforced compared to the old Medical Device Directive (MDD). Understanding and meeting these requirements is not just a legal necessity; it is ...
ISO 15223-1:2021/Amd 1:2025 and what it means for you
As many industry stakeholders may be aware, an amendment to ISO 15223-1:2021 was released last month. This update has generated some uncertainty among manufacturers regarding its implications and the necessary next steps. This article aims to clarify the key elements of the amendment and provide practical guidance on how to respond. It is important to ...
Important Dates for Manufacturers
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 ...
MEDTECH Europe Issue Decision Making Flowchart Regarding Article 10a MDR/IVDR
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 ...
Various European Organisations Publish Joint Discussion Paper on the Future Governance of Medical Technologies in Europe
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 ...
MEDTECH Europe Issue Position Paper on Submission of vigilance reports to Notified Bodies under EU MDR & IVDR
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. ...
UPDATE: ISO 15223-1:2021
The latest amendment to ISO 15223-1:2021 (Amd 1:2025) has been published, introducing crucial updates to enhance global compliance, clarity, and consistency in medical device labelling. As regulatory requirements evolve, these changes are essential for manufacturers, authorised representatives, and other stakeholders to ensure seamless international acceptance of their products. The key updates include: The updated standard ...
Commission launches a public consultation and a call for evidence for EU Medical Devices evaluation
The European Commission has initiated a public consultation and call for evidence as part of a targeted evaluation of the EU legislation on medical devices and in vitro diagnostic medical devices. This consultation offers stakeholders the chance to share their views on the effectiveness of the current regulations and identify any potential shortcomings. The regulations ...
Consultation, EU, IVDR, MDR
New Consolidated Version of the MDR Released in HTML Format
A New consolidated version of the MDR has been published in .html format with the inclusion of Article 10a. The .pdf version is expected to be released in January 2025. The .html version can be accessed using the following link
