EUDAMED is a central database and an important component of the MDR and IVDR. It is used to collect and manage information about medical devices, thereby contributing to their safety and traceability. Its goal is to create transparency for patients. They can obtain information about relevant products using the Unique Device Identifiers (UDIs). Whether it’s a new hip joint, a pacemaker, or just the scalpel used in surgery. There are various ways to enter product data into the database. One of them is through specialized software solutions. Some use locally installed servers, while other offerings use a cloud. You will learn about the advantages and disadvantages of the cloud solution in this text.
Manufacturers are responsible for entering the UDIs into EUDAMED. For the manual method, manufacturers only need access to EUDAMED. The other two methods, the XML bulk upload and the machine-to-machine (M2M) connection, require (external) software to establish the format and connection to EUDAMED. In both cases, the European Commission recommends seeking external help. A cloud solution offers flexible and scalable options for entering UDIs into EUDAMED.
What is a cloud solution?
Cloud services, especially Software as a Service (SaaS), offer a variety of advantages, including for managing UDIs. They feature automatic updates, as well as high availability and security. The security of cloud solutions is often unjustly questioned. It is assumed that data, since it is not stored on own servers or hard drives, is more vulnerable to cyberattacks. However, this is a fallacy. If companies have an on-premise solution for their data, the necessary facilities must be protected and maintained independently. This requires a great deal of expertise and effort, resulting in high costs. A cloud provider specializes in exactly this.
For example, tracekey creates multiple backups for customer data. These are stored in redundant systems in Western and Northern Europe. Should an entire data center fail, this distribution still ensures high availability and security. Storing data on European servers also complies with most data protection regulations (e.g., GDPR), and tracekey meets other high IT security standards that protect our customers’ data. A cloud solution for EUDAMED also offers other advantages:
- Scalability: Cloud solutions can be easily adapted to the needs of a company, whether it is a small startup or a large multinational corporation.
- Cost efficiency: By using cloud services, high investment costs for hardware and software are eliminated. Instead, companies only pay for the resources they actually use.
- Flexibility and mobility: Employees can access cloud services from anywhere, increasing collaboration and productivity.
- Automatic updates: Cloud providers take care of regular updates and maintenance, so companies always use the latest features and security updates.
The disadvantages of cloud solutions include dependence on the internet. A failure can therefore impair functionality. Additionally, cloud providers can also fall victim to cyberattacks or data leaks. However, on-premise servers are also exposed to this risk. When it comes to ransomware, cloud solutions have another major advantage. Since the data is not stored locally in the company, it is not possible for hackers to encrypt it in such a way that the company completely loses access.
What are the requirements for uploading data to EUDAMED?
In a recently published guideline by the European Commission (EC), the requirements for the three upload options are addressed. According to this, the simplest option, the EUDAMED user interface, only requires a PC and an internet connection. For the XML upload, it gets a bit more complicated. It is recommended to use an external system, with IT team members assisting in the implementation. In the case of the M2M connection, the EC assumes that dedicated hardware and regular maintenance are necessary. With our cloud solutions for EUDAMED, whether the UDI Manager or mytracekey MedTech, only a PC with an internet connection is required in all cases. This allows companies to upload their master product data pre-validated and compliant into EUDAMED.
The M2M connection as a cloud solution
An M2M connection enables automated communication between different systems. In the context of EUDAMED, an M2M connection can be used to transfer UDIs directly from a company’s internal system to the database in the correct format. The creation and uploading of XML files is skipped. This solution also offers the advantage of minimizing errors and speeding up the data entry process. A cloud-based M2M solution helps simplify UDI management and ensure compliance with the upcoming EUDAMED deadline. It also saves a lot of time with higher UDI volumes.