In accordance with the dispositions of the directive 98/79/EC, the European Authorized Representative (EC REP) has the obligation to inform all countries concerned of discontinuation of placing in vitro diagnostic medical devices onto the European Economic Area (EEA) in addition to the country where he has his registered place of business. The notification of discontinuation needs to be completed country by country as long as the European database (EUDAMED) does not exist (Reference: IVDD 98/79/EC, Article 10 (1); Commission Decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed)).
Informing the EC REP of the device discontinuation is the sole and entire responsibility of the manufacturer.
In vitro diagnostic medical devices have been discontinued? – Steps needed to be fulfilled:
Manufacturer provides EC REP with:
• The exact list of discontinued devices
• The exact list of EU States concerned by the discontinuation of devices
• Updated Declaration of Conformity (if relevant)
EC REP notifies the discontinuation of device(s) to the relevant EU authority of the EU State of his registered place of business (to Belgium in our case).
EC REP notifies the discontinuation of device(s) to relevant EU state authorities concerned of the discontinuation.