
In this episode, Oliver Harris delves into the specific requirements under the MDR as they apply to legacy devices, based on MDCG 2021-25 Rev. 1. He covers essential obligations for manufacturers, authorised representatives, importers, and distributors, including quality management systems, technical documentation, vigilance reporting, and post-market surveillance. Key exemptions for legacy devices are also highlighted, along with important transitional provisions. The discussion emphasizes the balance between regulatory compliance and patient safety during the MDR transition period.