Manufacturer are responsible for making sure that the devices they place on the market bear the CE marking, are accompanied by the required information and labelled in accordance with the Regulation, and have been assigned a UDI where applicable.
In addition, the manufacturer has to verify that devices are registered in EUDAMED.
At EUDAMED all economic operators and EU Authorised Representatives should be registered in this electronic system for registration. Each EU Authorised Representative, which fulfill obligations mentioned in the MDR/IVDR, will obtain a single registration number (SRN) and will be verified in a public database.
A manufacturer outside of the European Union and without a presence or an address in the EU and selling products to EU consumers must have an EU Authorised Representative.
• BZT as EU Authorised Representative will arrange for you all product registration processes.
• Prepare all application documentations
• Track and review application processes