EU: "potential serious risk" definition for devices
This article was originally published in Clinica
The European Commission's Directorate General Enterprise is to publish a list of examples of issues that would not normally be considered as grounds for a "potential serious risk to public health" in the context of Directive 2001/83/EC, the Community code relating to medicinal products for human use. The examples promise to be useful to manufacturers of combination products and products on the drug/device borderline area, as well as of general background use to all manufacturers of medtech products.
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