The launch of medical devices in Italy is not limited to compliance with Italian regulations. Given that Italy is a member of the European Union, companies must also consider the European regulatory framework. An essential component of this framework is the European Medical Device Vigilance System.
Here’s an overview of what it entails and how companies can best prepare.
1. What is the European Vigilance System?
The system is used to monitor and ensure that medical devices available on the European market are safe and meet the required standards. It acts as a filter, identifying and managing any incidents related to medical devices.
2. The role of MDR (Medical Device Regulation)
The MDR is a regulation that has introduced new and stricter rules for the certification and supervision of medical devices in Europe. Every company planning to launch a product in the European market must ensure compliance with the MDR.
3. EUDAMED: the European database
EUDAMED is a centralized database where all information related to medical devices marketed in the EU is recorded. Companies are required to provide and update data about their products on this platform.
4. Competent Authorities and Notified Bodies
Notified bodies are independent entities that are responsible for assessing the compliance of medical devices with regulations. The Competent Authorities, on the other hand, are the national bodies that oversee the proper functioning of the system at the local level.
5. Incident reporting and management
If a medical device causes a problem or incident, it must be reported. The European system has well-defined procedures for reporting and managing such incidents, ensuring that appropriate action is taken.
Navigating the European Medical Device Vigilance System may seem like a challenge, but it is an inevitable and vital component for those who want to operate in the European market. Preparing in advance and having a clear understanding of the system can make the difference between a successful launch and potential roadblocks.
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