26 March 2020
Supplying medical devices without CE mark in the Netherlands during COVID-19
In response to the COVID-19 outbreak, the Dutch Healthcare and Youth Inspectorate grants manufacturers and suppliers of medical devices the temporary opportunity to supply medical devices without a CE mark or without having followed the relevant assessment procedure.
In the course of March 2020, the Dutch Healthcare and Youth Inspectorate (IGJ) posted several updates on its website with regard to the use and supply of medical devices during the COVID-19 outbreak: It explicitly prohibited the use of unapproved COVID-19 self-tests, announced that requests for a license to export personal protection equipment outside the EU will, in principle, not be granted and concluded that certain masks that are approved in countries outside of the EU are equivalent to FFP2- and FFP3-masks that meet the EU standard EN-149 2001.
Due to the potential supply shortages of certain medical devices, as of 23 March 2020, the IGJ grants manufacturers and suppliers of medical devices the temporary opportunity to supply medical devices without a CE mark or without having followed the relevant assessment procedure.
The conditions for supplying these "unapproved" devices without a CE mark in the Netherlands are as follows:
- The health care institution must explicitly ask for the devices;
- The health care institution bears the responsibility for the use of the devices; and
- There are no alternatives with a CE mark available.
When supplying class I devices, manufacturers and suppliers do not have to notify the IGJ in advance. For devices belonging to a higher risk-class, notification to the IGJ is obligatory before supplying the products.
Lastly, the IGJ notes that the health care provider should carefully and responsibly assess purchasing devices without a CE mark. Because health care providers that choose to purchase devices without a CE mark will be held accountable, the IGJ requires them to record their considerations and decisions in this regard.
Authored by Wouter van Beek. For more information, contact Hein van den Bos.