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General Product Safety Regulation (GPSR 2023/988) Explained | QNET BV
Introduction The European Union has adopted the General Product Safety Regulation (GPSR) 2023/988, which replaces the previous General Product Safety Directive (GPSD 2001/95/EC)**. The GPSR introduces stricter safety requirements and modernized rules to ensure that all products on the EU market are safe, particularly addressing challenges posed by online sales,…
Navigating the EU AI Act Regulation 2024/1689: Impacts on Medical Device Software (MDSW)
The EU AI Act: How It's Transforming AI in Healthcare and Medical Devices The EU AI Act (Regulation 2024/1689) is a groundbreaking legislation governing artificial intelligence (AI) systems across the European Union. As its first comprehensive regulatory framework, the Act has profound implications for AI, particularly in healthcare and medical…
Post-Market Surveillance (PMS): Ensuring Compliance Across the EU, UK, and Switzerland Requirements
Executive Summary PMS is a regulatory requirement that systematically monitors a medical device's safety, performance, and quality once it enters the market. PMS processes allow manufacturers to collect real-world data, assess device efficacy, and ensure long-term compliance with regulatory standards. QNET, as your Authorized representative in the EU, UK, and…
Preparing for IVDR Compliance – Key Focus Areas for Notified Body Assessments under Regulation (EU) 2024/1860
Introduction With the implementation of Regulation (EU) 2024/1860, the requirements and timelines for in vitro diagnostic medical devices (IVDs) under the In Vitro Diagnostic Regulation (IVDR) 2017/746 have been updated. These changes address the practical challenges of compliance and ensure that essential IVDs remain available in the European market. We…
Phthalates Benefit-Risk Guidelines
The EU's Medical Devices Regulation (MDR) addresses requirements for using CMR and/or ED substances in Chapter II Section 10.4 of Annex I (MDR). The commission’s Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) finalized its revised phthalates benefit-risk assessment guidelines on June 17, 2024. Under the MDR, these guidelines…
(EU) Regulation 2024/1689, the so-called "AI Act" (AIA), and the MDR/IVDR
Software (including AI) for medical purposes is regulated in Europe and the United Kingdom as a medical device. It requires comprehensive assessment before being placed on the EU and UK market under Medical Device Regulations (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR). The European Union (EU) has introduced new legislation on…