Apr 6, 2023
EU MDR/IVDR
Medical devices are an integral part of healthcare, and their safety and efficacy are critical to ensure patient well-being. In 2017, the European Parliament and Council adopted the new Medical Devices Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) to...
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Mar 23, 2023
Asia
The new article highlights the aspects related to the recalls and withdrawals initiated by the authority or by a party responsible for a medical device itself. Table of Contents The Turkish regulating authority in the sphere of healthcare products has recently...
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Mar 6, 2023
Asia
The article provides an overview of the regulatory requirements related to recalls and withdrawals for general and in vitro diagnostic medical devices allowed to be marketed and used in Turkey. Table of Contents The Turkish regulatory agency in the...
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Feb 28, 2023
EU MDR/IVDR
The article highlights the key points associated with the substantial changes to performance studies in the context of the new regulatory framework. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission...
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Feb 8, 2023
EU MDR/IVDR
The Council of the European Commission concluded in a meeting on December 9th to address member states’ concerns over the challenges and issues in meeting current EU Medical Device Regulation (MDR) deadlines. Table of Contents Regulatory Background According to...
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