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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…
MHRA: proposed framework for international recognition of medical devices
This initiative signals an important step towards a new regulatory framework for medical devices in the UK that protects public health, ensures access to MedTech innovations, and maintains an attractive market for the industry. The framework ensures safe access to quality-assured medical devices, reduce the duplication of assessments by comparable…
The New Regulatory Framework - UK
The MHRA previously confirmed that it would use expertise and decision-making from comparable regulator countries (CRC), (CRC countries are the EU, US, Australia, and Canada), to bring medical devices to the UK market. Within the system of recognition and trust, the so-called Reliance Route for Market Authorization (MA) framework, the…