Borderline Devices: Definitions and Requirements
This White Paper provides the necessary definitions and requirements for borderline devices, in particular for substance-based devices including a medicinal product with an ancillary function, according to MDR (EU) 2017/745.
1.INTRODUCTION
Borderline devices are those products that by their nature do not immediately relate to a specific sector, for which it is therefore difficult to define which regulation should be applied. […]
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