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Implant Passport: you can manage it with OrisDent Q


Implant passport: OrisDent Q is ready!

Following the media outcry caused by some accidents because of adverse reactions to certain types of prostheses, a previous European standard in force since 1997 (EEC Directive 93/42) was replaced. It provides for the obligation to conserve and identify the devices. A system based on a unique device identifier (UDI. More information at the following link) that facilitates the traceability of medical devices. For this reason we have created the Implant Passport  for the Dental Practice Management Software OrisDent Q, available at no additional cost.

In this article we report in points what is important to know about:

Lack of Information for the Patient: 

  • The lack of clear information to the patient regarding the type and origin of the Medical Devices (MD) used has generated the need to introduce a unique identification code (UDI);
  • In this context, a European database called EUDAMED was created to trace the entire supply chain of implantable MD, from the manufacturer to the end user throughout Europe.

Implant Passport in The Dental Practice Management Software OrisDent Q in compliance with the Regulations:

  • OrisDent Q is ready to support you! In compliance with this regulatory obligation, we have created the Implant Passport. It is a document that includes essential information e.g. the unique identification of the device, name, serial number, lot number, UDI, model and the name with the website address of the manufacturer;
  • You will be able to print this document to give to the patient with all the information, leaving the implants always traceable.