Foreign companies must comply with US Medical Device Reporting regulations (MDR)
This article was originally published in Clinica
While the US FDA considers alternative proposals to the US designated agent requirements, foreign manufacturers are responsible directly for complying with the new medical device reporting regulations which came into effect last week. The agency decided to suspend enforcement of the US designated agent and manufacturer certification provisions in June in response to industry concerns (see Clinica No 709, p 7). The agency has proposed revisions to these requirements.
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