To ensure transparency amongst stakeholders of medical devices, and to enable better access to information for the general public, the European Union has envisioned a kind of IT System named the European Database on Medical Devices. It comprises various interconnected components. Although it is not fully functional now, manufacturers must prepare to meet the impending deadline. This Page will assist you in just that.
The European Database on Medical Devices is an IT system and Online Database developed by the European Commission to implement regulations on medical devices.
It has been introduced to ensure the traceability of medical devices (and IVDs [In Vitro Diagnostics] ) within the supply chain, strengthen market surveillance, and ensure transparency in the market.
Objectives of EUDAMED:
It enables better access to information for the public and healthcare professionals, also enhancing coordination between member states in the European Union [EU].
Meets the requirements mentioned in EU MDR 2017/745 and EU IVDR 2017/746.
To provide a living picture of the Lifecycle of medical devices that are made available in the European Union.
To integrate different electronic systems to collate and process information about medical devices and related stakeholders(companies, manufacturers)
Foster collaboration between different stakeholders including the public, with an emphasis on public safety and clinical evidence.
Modules of EUDAMED:
The EUDAMED is structured around 6 interconnected modules and a public website:
Currently, the first three components are active. The manufacturer should register first as an actor and then proceed to device registration.To register, manufacturers need to create an account and accurately fill in the required information.
Is Using EUDAMED Compulsory?
Although Using this new database is not mandatory, manufacturers are highly encouraged to register as actors and their devices.
Who Must Register for EUDAMED?
Economic Operators (Manufacturers, Authorised Representatives, System and Procedure Pack producers, and importers) are those based in or outside the European Union. If they are involved in selling products into the EU Market or using the CE Mark.
Important Numbers & Code Relevant to EUDAMED
SRN Number : as soon as the competent authority has accepted the actor registration, each actor receives an SRN (or actor ID). It is composed of first the country code, like “BE” for Belgium followed by the Actor role abbreviation (like “MF” for the manufacturer) and nine digits.
EMDN (European Medical Devices Nomenclature) : they are codes that group medical devices in sets of terms or nomenclatures and are important to register in EUDAMED.
Basic UDI-DI : They are a set of codes that group the medical device with the same intended purpose, risk class, and essential design & manufacturing characteristics.By contrast to UDI-DI,the Basic UDI-DI does not appear on the labels of devices.
Steps to Register at EUDAMED:
After the technical documentation has been compiled and the EU Authorization Representative has been appointed (if required), the manufacturer may start the registration process.
This process:
is for all risk classes of medical devices and IVDs in the EU Markets
Should be completed before the appointment of the Notified Body for assessment of conformity assessment procedure, as applicable.
Step1 : Basic UDI-DI and UDIs
Issuing Entities (designated by the EU Commission ) such as IFA GmbH, GS1 AISBL, Health Industry Business Communications Council, and ICCBA give the basic UDI-DI and UDIs respectively.
Step2 : Registration of EU Representatives, Manufacturers and Importers
Economic operators must register themselves in the Actor Registration Module where information regarding them and their device must be entered.
After verification of the information entered, the Authority will issue (to Economic Operators) an SRN (Single Registration Number) from the Electronic system.
This SRN can be used by manufacturer for applying to notified body for conformity assessment.
Step3 : Registration of Devices
In the device registration modules, basic UDI-DI is entered followed by other information related to the medical device (like quantity per package, name, address of manufacturer and SRN, and member state information.
For low-risk Medical devices and In Vitro Diagnostics, followed by the registration process,
As per guidelines, the EU Declaration of Conformity needs to be prepared for the market launch.
For high-risk Medical devices, the notified body‘s involvement is essential for conformity assessments. The manufacturer should prepare the EU declaration of conformity (upon the audit approval for CE Marking ) for market launch.
If you need guidance specially crafted for your medical device, then you can contact us with your query. Our team of experienced regulatory experts will help you in increasing market access to your products in the European Market.
