Instruction to register the supply of alternative medical devices
A manufacturer, authorised representative, distributor, or importer can register the supply of an alternative medical device with the IGJ for medical equipment (class IIa/b and III) that do not carry a CE marking or that have not gone through the normal conformity assessment procedure.
An exception to this procedure is applicable for medical devices (like ventilators) and in-vitro diagnostics (tests) which are purchased via a central national working group initiated by the Ministry of VWS. Manufacturers and suppliers are requested to send specifications and information about the fulfilment of technical and clinical requirements to meldpunt@igj.nl. The inspection will forward the information to the relevant working group.
Registrations can be submitted by email to meldpunt@igj.nl while referencing “Corona request care provider class II/III”.