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European regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) require precise definitions in technical documentation, and the distinction (or overlap) between intended purpose and intended use remains a topic of operational significance. This bulletin clarifies the regulatory definitions, their implications, and guidance interpretations.
MedNet EC-REP GmbH is pleased to announce that we will once again be exhibiting at MEDICA 2025 in Düsseldorf, the world’s leading trade fair for the medical technology industry. From 17 to 20 November 2025, you will find us at Hall 3, Booth D43.
On 12 September 2025, the European Commission published Version 4 of the Manual on Borderline and Classification under Regulations (EU) 2017/745 and 2017/746, developed by the Borderline and Classification Working Group (BCWG). This updated manual provides revised guidance on determining whether a product is a medical device (or in vitro diagnostic device), dealing with borderline cases, and applying the classification rules under MDR and IVDR. Regulatory affairs professionals should be aware of both the new content and the practical implications for compliance.
The European Commission has introduced a significant amendment to Implementing Regulation (EU) 2021/2226, impacting how medical device manufacturers provide instructions for use (IFU). This update, outlined in the latest draft Commission Implementing Regulation, aims to expand the scope of electronic Instructions for Use (eIFU) to a broader range of medical devices, reflecting a clear preference among healthcare professionals for digital access to critical information. This article summarizes the key changes and their implications for the medical device industry.
The regulatory landscape for medical devices and in vitro diagnostic medical devices is continuously evolving, with the introduction of new technologies like Artificial Intelligence (AI) adding layers of complexity.
The European Medical Device Coordination Group (MDCG) has released its latest guidance, MDCG 2025-5, a comprehensive Questions & Answers document addressing performance studies for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR).
In the dynamic world of medical device regulation, staying abreast of the latest guidance is paramount for manufacturers. The Medical Device Coordination Group (MDCG) has recently released a significant update to its MDCG 2019-11 guidance document, now designated as MDCG 2019-11 Rev.1.
The European Commission's Medical Device Coordination Group (MDCG) has released the MDCG 2025-4 guidance document, titled "Guidance on the safe making available of medical device software (MDSW) apps on online platforms." This document, published in June 2025, clarifies the regulatory obligations for all parties involved in bringing MDSW apps to the EU market, with a particular emphasis on online platform providers. This article provides a concise overview of its key takeaways for regulatory professionals.
The European Commission has released a new version of the Manufacturer Incident Report (MIR) form-MIR 7.3.1-which will become mandatory for all medical device and IVD manufacturers from November 2025. This update is a significant step in harmonizing and streamlining incident reporting processes across the European Union, in line with the MDR and IVDR requirements.
The European Commission is hosting a free, hybrid EUDAMED workshop in Stuttgart on May 21, 2025, designed to support the onboarding of all actors involved with the European Database on Medical Devices (EUDAMED).
The European Commission has taken a significant step in strengthening the regulatory framework for medical devices by harmonising additional standards under the Medical Device Regulation (MDR, EU 2017/745). The latest update, formalised through Commission Implementing Decision (EU) 2025/681, introduces new harmonised standards covering medical gloves for single use, sterilisation of medical devices, and patient handling equipment in ambulances.
The Medical Device Coordination Group (MDCG) published Revision 4 of its guidance document MDCG 2020-16, titled "Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746". This updated version provides further clarification on the application of the classification rules outlined in Annex VIII of the IVDR.