The main purpose of the EUDAMED database is to enhance traceability, cooperation, and transparency regarding medical devices in EU. The database is huge and has been split up into six different modules with specific purposes. This article will cover the areas that each one of the modules covers. One of them is EUDAMED login information which you can find in a separate article.
The video below is a part of our online course Introduction to the Medical Device Regulation (EU) 2017/745 and explains the topic in greater detail.
Notified bodies and certificates
This module will be used by the commission, the competent authorities, and the notified bodies. Parts of this module will be available to the public, such as certificates issued by notified bodies for conformity assessments. This is also where the SSCPs will be found.
A notified body that refuses a manufacturer a certificate must report this information to this part of EUDAMED so that other notified bodies are aware of the situation. This is also true if a manufacturer has terminated the conformity assessment for some reason.
In this module, manufacturers apply, follow up, and report on their clinical investigations. The manufacturers must disclose what they want to achieve with their clinical investigations before they start them.
If a clinical investigation is terminated for some reason, this shall also be reported here. A lot of this data is accessible to the public.
Vigilance and post-market surveillance
The vigilance and PMS module is where the manufacturer needs to report any serious events with their devices, along with field safety corrective measures, and related Basic UDI-DI and UDI data for the affected devices.
The trend reporting from the PMS system must also be uploaded to this module along with Periodic Safety Update Reports (PSURs) for the manufacturers. The data in this module will only be partially available to the public.
This market surveillance module is primary for authorities to use for communication. However, the market surveillance reports shall be made available to the public by the authorities of each member state.
All medical devices must have a UDI-DI on the UDI carrier, the label. However, not all data related to a device will fit on the UDI carrier. This is where EUDAMED comes into the picture.
Once you have obtained an SRN from the actor registration module, you can start to register devices. The first thing to do is to assign a Basic UDI-DI to the device or devices you want to register.
The Basic UDI-DI management shall be done according to your QMS, and the Basic UDI-DI code shall follow the nomenclature of the issuing entity (code supplier). There is specific data that needs to be included in the Basic UDI-DI. This Basic UDI-DI will cover one or many UDI-DIs. This must be kept track of in your QMS as well.
After that, the actual device registration in EUDAMED can start. Only the UDI-DI part of the UDI is to form input into EUDAMED. And once inside the EUDAMED device registration module, EUDAMED will recognise the SRN for linking devices to economic operators. During the device registration, you also have to specify what Basic UDI-DI the device (UDI-DI) you are registering belongs to.
You need to enter all the relevant device data corresponding to the specific UDI-DI you are registering in the device registration module.
The mandatory data that needs to be put into EUDAMED for each UDI-DI is:
- UDI-DI value*
- UDI-DI Issuing Entity*
- Reference, Article or Catalogue number*
- Device with Direct marking (Y/N)*
- Quantity of device(s)*
- Type of UDI-PI*
- Labelled as single use (Y/N)*
- Device labelled as sterile (Y/N)*
- Need for sterilisation (Y/N)*
- Containing latex (Y/N)*
- Medical device nomenclature code
- Device Status
- Reprocessed single-use (Y/N)*
- Member State of the Placing on the EU Market of the Device*
*This data may not be changed without a new UDI-DI assigned.
Plus there is at least an equal amount of data required “as applicable”. The UDI-DI data that is potentially required can be found here. This is a lot of data, especially if you have many devices. But there are ways, besides manual entry, to communicate with EUDAMED in more efficient ways.
For example, you can upload xml-files with the data and there is, or will be, ways for machine-to-machine solutions to facilitate communication when there is a need to transfer larger amounts of data.
If you want to know more about the European database on medical devices you can read the EUDAMED user guide. Do not miss our other articles relating to the medical device industry.
Would you like to know more about the Medical Device Regulation?
If you want to know more about understanding the European regulation for medical devices, take a look at our online Introduction to the Medical Device Regulation (EU) 2017/745 course. This online course is an in-depth overview of the Medical Device Regulation according to (EU) 2017/745 as well as related guidances, like MDCG, and how to apply to a notified body for conformity assessment.
It is suitable for anyone working with regulatory questions, such as RA and QA engineers, PRRC or management.
Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.
He has vast experience in the MDR and its implementation thru hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.
He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.