Temporary supply of medical devices without CE mark

The outbreak of the corona virus can cause shortages of regular medical devices. The Inspection of Healthcare and Youth (IGJ) temporarily gives manufacturers and suppliers the opportunity to supply medical devices that do not have a CE mark or have not gone through the normal assessment procedure. Under certain conditions: the healthcare institution must explicitly request the alternative and takes the responsibility for its use. There must also be no approved alternatives available.

 

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Source: Ministerie van Volksgezondheid, Welzijn en sport - Inspectie Gezondheidszorg en Jeugd