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MHRA Guidance on Stand-alone Software Medical Devices

Medical device apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices. In the UK, medical devices are subject to UKCA marking. The UKCA marking is no exception to software medical devices. MHRA Guidance on Medical Devices Software Medical Devices or not Classifying software or a mobile app as a medical device can be challenging. If t...
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Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Introduction Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and conditions for placing certain medical devices on the market or putting them into service. This comprehensive analysis explores the key points of these amendments, focusing on the intricate timeline considerations.  Paragraph 3 Amendments Paragraph 3 has undergone crucial revisions, introducing new provisions (3a to 3g) that o...
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