What is the EUDAMED Database?
EUDAMED is the European database for medical devices developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.
EUDAMED will be a multipurpose system, functioning as a registration system, a collaborative system, a notification system and a dissemination system and will be interoperable. The aim for EUDAMED is that there will be more transparency about medical devices that are available on the EU market during the entire lifecycle of a medical device. As such, the information in EUDAMED is also accessible by the public.
EUDAMED consists of six modules that work together and are accessed via a secure online portal. The six EUDAMED modules are:
Unique device identification (UDI)/Devices registration
Notified Bodies and Certificates
Clinical Investigations and performance studies
Vigilance and post-market surveillance
As of 31 July 2021, the EUDAMED database is still being developed and only the Actors registration module is available.
EUDAMED & European Medical Device Regulations
One of the fundamental aims of the European Medical Device Regulations is to protect public health and safety. It does this by:
Improving the quality, safety and reliability of medical devices by imposing stricter controls on high-risk devices, clinical evaluations, investigations and the notified bodies that approve the certification of medical devices.
Strengthening transparency and information available to patients by making information related to a medical device easier to find.
Enhancing vigilance and market surveillance so that medical devices are still monitored even after they have been placed on the market.
Information about all the activities related to these three areas will be stored in EUDAMED, making it easier to access information for any specific medical device.
What is the procedure to register as an Actor in EUDAMED?
Every economic operator wishing to release a medical device on the EU market has to register as an Actor in EUDAMED.
To register as an Actor, the economic operator must submit an actor registration request in EUDAMED. The request is then processed according to whether the economic operator is from the EU or not. When an economic operator registers as an Actor, they obtain an actor identifier or single registration number (Actor ID/SRN) that uniquely identifies them in EUDAMED. Details of the process have been described by the European Commission in the document Actor Registration Request Process.
There are different Actor roles that an economic operator can apply for:
system/procedure pack producer
Note: distributers are not economic operators and therefore do not have to register in EUDAMED.
If an economic operator has multiple roles, then they will have to register as an Actor in EUDAMED for each role as the SRN contains a designation of the specific role.
What is stored in EUDAMED?
The information stored in EUDAMED is separated into six categories (six modules):
Actors registration: Economic operators in the different roles must register in EUDAMED. Once their registration request has been approved, they have access to EUDAMED for the role that they have registered.
UDI/Device registration: All devices must be registered in EUDAMED and obtain a UDI.
Notified Bodies and Certificates: All medical devices on the EU market must have a certificate confirming that the product complies with all regulatory requirements for medical devices. The certificates are logged in EUDAMED.
Clinical Investigations and performance studies: The new medical devices regulations require that manufacturers conduct a clinical evaluation of all their products, regardless of risk class. This evaluation process verifies the manufacturer’s safety and performance, including clinical benefit even after the product has been released. These evaluation reports must be logged in EUDAMED.
Vigilance and post-market surveillance: Vigilance and post-market surveillance are two important aspects of the EU medical device regulations. Any serious incident involving the medical device must be documented and logged in EUDAMED.
Market Surveillance: Competent authorities conduct market surveillance on certified medical devices. The reports of the market surveillance are logged in EUDAMED.
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