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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…

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…

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 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…