Registration of the
Registration of the Medical Device
Once the CE Marking of the Medical Device or the Medical Device for In Vitro Diagnostics has been obtained, it is necessary to register or notify its placing on the market in the EU country where the manufacturer is located. In the case of Spain, the registration or notification of the product must be made to the AEMPS, in France to the ANSM, etc.
Depending on the classification of the medical device or in vitro diagnostic product, the AEMPS requires either a registration of the manufacturer or a notification, actions that entail different documents and fees.
At deviCE Sistemas we can process the registration of your products.
Moreover, with the advent of Regulations (EU) 745/2017 MDR and 746/2017 IVDR, registration in EUDAMED will also be required.
EUDAMED is an EU-wide database that will encompass all aspects related to Medical Devices: registration of manufacturers, importers, authorised representatives and notified bodies, technical documentation of devices, UDI codes, clinical evaluation, etc.
So far EUDAMED is optional and only the module for registration of economic operators is open.
The registration of actors in EUDAMED is necessary for the Competent Authority of each country to grant the corresponding actor its SRN number. The SRN is the unique registration number.