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 ...
UPDATE: MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
The guidance document MDCG 2020-16 has been recently updated. To offer some background to this guidance document, originally published in 2020, this guidance document provides clarification on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR), focusing on Annex VIII classification rules. It applies to diagnostic services performed on EU ...
Latest Consolidated Version of IVDR Published
The Latest version of the IVDR has been published in HTML format. The .pdf version is expected to be released in the near future. To access the latest consolidated version of the IVDR, click on the following link
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
Importance of Importers in the MDR/IVDR
Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), an importer is defined as any natural or legal person established within the European Union who places a medical device from a third country onto the EU market. The key criteria for an importer, as specified in the regulations, are: Obligations of Importers The obligations ...
Classification Rationales
In the rapidly evolving European regulatory landscape, correct classification of medical devices and in vitro diagnostic medical devices (IVDs) under the Medical Device Regulation (MDR, EU 2017/745) and In Vitro Diagnostic Regulation (IVDR, EU 2017/746) is pivotal. Misclassification can lead to delays in market access, costly rework, compliance risks, and, most importantly, patient safety issues. ...
Guidance on Borderline Products
The Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) provide comprehensive and detailed definitions that clearly outline what qualifies as a Medical Device and an In Vitro Diagnostic Medical Device. These definitions are essential, as they serve as the foundation for determining the regulatory pathway for products within the European Union. The ...
