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More control on Dutch class 1 medical devices

From 01 April 2014, on the initiative of the Health Care Inspectorate (HCI) of the Netherlands and in cooperation with Neprofarm and KOAG/KAG, all new introduced class 1 medical devices in the Netherlands will have to be assessed by an expert to assure that the product complies with the legal definition of a medical device, that the legal classification rules of class 1 medical device are applied correctly and that the clinical evidence supporting claims made of the medical device are justified.
For all class 1 medical devices already on the Dutch market, the manufacturer has untill 01 January 2015 to perform this assesment by an expert. This action is the result of a report of KOAG/KAG stating that the definition and classification used for 1 out of 4 class 1 medical devices on the Dutch market is questionable.

If the assessment is not performed for a class 1 medical device , the KOAG/KAG will not evaluate any advertising or promotion of the product.

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