Medical Device Registration
Once the CE Marking of the Medical Device or In Vitro Diagnostic Medical Device is obtained, it is necessary to carry out the registration or notification of its market placement in the EU country where the manufacturer is located. In the case of Spain, the product registration or notification will be carried out with the AEMPS, in France with the ANSM, etc.Depending on the classification of the Medical Device or in vitro diagnostic product, the AEMPS requires the completion of a manufacturer registration or a notification, actions that involve different documents and fees.
At DeviCE Sistemas, we can process the registration of your products
Furthermore, with the arrival of the Regulations (EU) 745/2017 MDR and 746/2017 IVDR, registration in EUDAMED will also be necessary.EUDAMED is the IT system developed by the European Commission, in the form of a database for the entire European Union that will encompass all aspects related to Medical Devices: registration of manufacturers, importers, authorized representatives, and notified bodies, technical documentation of products, UDI codes, clinical evaluation, etc.A versatile system is sought, acting as a registry, collaboration system, notification system, and dissemination system (open to the public) with the aim of improving transparency and coordination of information related to medical devices available in the EU market.
The registration of actors in EUDAMED is necessary for the Competent Authority of each country to grant the corresponding actor their SRN number. The SRN is the unique registration number.At deviCE Sistemas, we can assist you in the registration process as an “actor” in EUDAMED, generating the necessary documentation for the process, making it as simple as possible for you.Additionally, one of the elements that has significantly changed in medical device registrations is the need to obtain UDI codes. To obtain these codes (UDI-DI-BASIC, UDI-DI, and UDI-PI), it will be necessary to associate with one of the entities accredited by the European Commission to grant UDI.
