Actor Registration Module<\/strong><\/h2>\n\n\n\nOn 1st<\/sup> of December 2020, the European Commission made available the Actor Registration module; the first EUDAMED module to be operational.<\/p>\n\n\n\nAs a side note, as you might have noticed, EUDAMED is called MDR EUDAMED on the Actor Registration module landing page. That \u201cMDR\u201d in \u201cMDR EUDAMED\u201d apparently stands for \u201cMedical Device Regulation\u201d and EUDAMED itself is an abbreviation for \u201cEuropean Database for Medical Devices\u201d. So, the full name of the system is \u201cMedical Device Regulation European Database for Medical Devices\u201d. We\u2019ll stick with just EUDAMED for the rest of the text.<\/p>\n\n\n\n
You can log in to the Actor Registration module with EU Login details. If you do not have those yet, you can get them here. Once logged in, you can register as an Actor and request access to EUDAMED for the Actor.<\/p>\n\n\n\n
When you start the Actor Registration process, you are shown the following disclaimer:<\/p>\n\n\n\n
Disclaimer at the start of the Actor Registration process<\/p>\n\n\n\n
After you agree to the disclaimer, you can start creating the Actor. First, you select your role out of the following options:<\/p>\n\n\n\n
\n- Authorised Representative<\/li>\n\n\n\n
- Importer<\/li>\n\n\n\n
- Manufacturer<\/li>\n\n\n\n
- System\/Procedure Pack Producer<\/li>\n<\/ul>\n\n\n\n
Then, you select your country and enter the name of your organization.<\/p>\n\n\n\n
You are then requested to enter further information about your organization.<\/p>\n\n\n\n
You need to download, fill in and sign a \u201cdeclaration on information security responsibilities in the context of the European medical device database\u201d. This form basically asks for the same information you just provided in the previous pages of the registration form, but this time you need to either fill it in with a .pdf software or print it out, fill it by hand (and scan), sign it, and upload it to the registration form.<\/p>\n\n\n\n
As a last step, the registration form is sent to the National Competent Authority (NCA) of the Member State you have selected for review and approval. After their review, you are asked by the NCA to provide proof of payment for the registration. For example, with the Finnish authority Fimea, the cost of the registration is \u20ac500.<\/p>\n\n\n\n
The device companies and other parties are not required to use the Actor registration module until EUDAMED is fully functional according to the Medical Device Regulation. This means that additional national requirements on registrations can still be required by EU countries.<\/p>\n\n\n\n
<\/strong>UDI and Devices Registration Module<\/strong><\/h2>\n\n\n\nUnique Device Identifier (\u201cUDI\u201d) is a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market.<\/p>\n\n\n\n
The module on Unique Device Identification and device registration is the second EUDAMED module that became available. Along with the module of Notified Bodies and Certificates (third module), it has been available since October 2021. The current release of the module does not include the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities. Afterwards, the remaining modules as well as the mechanism for scrutiny and the CECP will be released when EUDAMED is fully functional.<\/p>\n\n\n\n
Unique Device Identification system<\/em><\/h2>\n\n\n\nThe Unique Device Identification system (\u201cUDI system\u201d) makes it possible to identify and trace medical devices. UDI system consists of the following functionalities:<\/p>\n\n\n\n
\n- Production of a UDI\n
\n- UDI device identifier (\u201cUDI-DI\u201d) specific to a manufacturer and a device<\/li>\n\n\n\n
- UDI production identifier (\u201cUDI-PI\u201d) that identifies the unit of device production and if applicable the packaged devices<\/li>\n<\/ul>\n<\/li>\n\n\n\n
- Placing of the UDI on the label of the device or on its packaging<\/li>\n\n\n\n
- Storage of the UDI by economic operators, health institutions and healthcare professionals<\/li>\n\n\n\n
- Establishment of an electronic system for Unique Device Identification (\u201cUDI database\u201d)<\/li>\n<\/ul>\n\n\n\n
UDI database<\/em><\/h2>\n\n\n\nUDI database is used to validate, collate, process, and make available to the public the information mentioned above.<\/p>\n\n\n\n
The UDI database is designed so that no UDI-PIs and no commercially confidential product information can be included therein. The core data elements of UDI database are accessible to the public for free. The EC will provide for technical and administrative support to device manufacturers and other users of the UDI database.<\/p>\n\n\n\n
<\/strong>Notified Bodies and Certificates Module<\/strong><\/h2>\n\n\n\nNotified Bodies and Certificates Modules is the third module that is currently available. According to the new regulations, the Notified Bodies should register in EUDAMED any information regarding certificates. This includes:<\/p>\n\n\n\n
\n- Issuing new certificates<\/li>\n\n\n\n
- Amendments and supplements to certificates<\/li>\n\n\n\n
- Suspending certificates<\/li>\n\n\n\n
- Reinstating certificates<\/li>\n\n\n\n
- Withdrawal of certificates<\/li>\n\n\n\n
- Refusal and other restrictions imposed on certificates.<\/li>\n<\/ul>\n\n\n\n
The European Commission cannot require the use of the module until EUDAMED is fully functional according to the Medical Device Regulation. So, currently, all information registered related to certificates and Summaries of Safety and Clinical Performance (SSCP) has been added on voluntary basis.<\/p>\n\n\n\n
For the Notified Body to be able to add certificate data into the module, it is required that all of the parties referenced in the certificates are first registered in the database because the certificates include the UDI-DI(s). The parties to be registered would include the manufacturer, the authorised representative (where applicable), and\/or the system procedure pack producer.<\/p>\n\n\n\n
The above information from the Notified Bodies about certificates is accessible to the public. At the time of writing this (16-Dec-2021) only one certificate had been registered to the module.<\/p>\n\n\n\n
A single registered certificate on 16th December 2021<\/p>\n\n\n\n
Certificate Unique Identifier<\/em><\/p>\n\n\n\nEach certificate in the module has a unique identifier. The certificate paper version unique identifier is identified by a unique number which is the \u201cNB number + Certificate number (+ possibly \u2018Revision number\u2019)\u201d. The EUDAMED Certificate data version is identified by the \u201cCertificate paper version unique identifier\u201d and the \u201cEUDAMED version number\u201d.<\/p>\n\n\n\n
The EUDAMED version number increases after any update of a certificate as for the certificate paper version identifier. If the certificate is withdrawn, suspended, or reinstated, there is a new EUDAMED version but not a new Certificate paper version.<\/p>\n\n\n\n