Medical devices

The impact of clinical data requirement
changes following EU Medical Device Regulation (2017/745) and Clinical Evaluation Guidance (MEDDEV 2.7/1 Rev 4)

By , and adapted for publication by Vinetta Brew2023-08-03T14:59:00

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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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