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15 May 2013
In line with the general trend in Europe, the Danish government has recently taken initiatives to increase control in the medical device industry.
With effect from July 1 2013, changes to the Medical Devices Act will impose new obligations on importers and distributors, in order to increase supervision of the market and allow the Danish authorities to identify all types of medical device imported into and distributed within Denmark.
The changes include:
Similar rules already apply to manufacturers of medical devices. In addition, an obligation to store invoices for at least five years will be imposed on distributors.
The authorities have also focused their attention on the relationship between healthcare professionals and the medical device industry. At present, the relationship between healthcare professionals and the pharmaceutical industry is subject to strict regulation, but few rules exist in the medical devices area.
In February 2013 a committee appointed by the Ministry of Health to review Danish regulation in this area published its recommendations, in which it generally suggested that the rules applicable to the pharmaceutical industry be imposed on the medical device industry. The ministry is reviewing statements following a public hearing.
The committee has proposed rules regulating both healthcare professionals' affiliations with and receipt of financial benefits from companies. With regard to affiliation, three different approaches have been suggested:
With regard to financial benefits, it has been suggested that the strict rules applying to pharmaceutical companies should also be extended to medical device companies, including those concerning advertisements and sponsored events. Should this be implemented, the general rule will be that financial benefits are not allowed as part of advertising or otherwise with the intention of promoting the sale of a medical device.
The Ministry of Health expects to publish a revised report at the end of May 2013.
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