Dutch Regulators Ease Language Requirements for Some Medical Devices

The Dutch Health Care Inspectorate (IGZ) has begun allowing user information for some medical devices to be provided in English based on certain conditions (link in Dutch).

IGZ rules that device user information be provided in Dutch are no longer applicable for devices used exclusively by healthcare professionals such as physicians and nurses. In these instances, user information in English will be sufficient as long as intended users have adequate knowledge of English.

Previously, medical device manufacturers commercialized in The Netherlands could request exemptions to Dutch language requirements if their products were intended only for medical specialists; users trained in how to use the device in question; and if their products were designed for regular, routine use.

Now, there is no legal requirement for manufacturers to request exemptions to language requirements.

Stewart Eisenhart

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