Impact of clinical data requirements following EU MDR (2017/745) & Clinical Evaluation Guidance (MEDDEV 2.7/1 Rev 4)

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The EU Medical Device Regulation 2017/745 (EU MDR) and guidance on clinical evaluation (MEDDEV 2.7.1 Rev 4) have replaced the previous regulations governing the placing of medical devices on the European market. Concerning that these new requirements may be difficult to implement and pose an additional burden to Medical ...

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