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New Danish executive order on device monitoring:

This article was originally published in Clinica

Executive Summary

The Danish ministry of health has submitted a draft amendment of the new executive order on medical devices to the medical devices trade association (Medicoindustrien) for review. The executive order was amended to incorporate legislation from the Medical Devices Act, adopted in December 2002 (see Clinica No 1037, p 6). This amendment will ensure that only devices that conform to the requirements of the executive order may be sold and distributed. The legislation also empowers the Danish medicines agency (Laegemiddelstyrelsen) to take action against distributors of medical devices that do not conform to the new requirements of the executive order.

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