EUDAPORT handles EUDAMED registration for medical device and IVD manufacturers

If your company acts as a manufacturer of medical devices or IVDs, then you are surely aware that the time is fast approaching when you will need to register all your devices in the pan-European EUDAMED database. However, you may not yet realize just how demanding this agenda will be – in terms of time, money, administration, regulation, and technology.

After thoroughly familiarizing ourselves with the entire EUDAMED database environment at Porta Medica, we came to the unequivocal conclusion that, at the very least for all our customers who are medical device and IVD manufacturers, we must find or create a tool that makes this process manageable and feasible for them. Right after our first attempt at manual data entry, it was clear that this was not the way to go. So we looked around to see if anyone in the EU had already created a functional tool for bulk data upload at a reasonable price. We come across such offers practically every day, but all of these tools suffered from at least one major flaw that makes them unusable for our customers. For example, some tools merely converted data into an XML structure without validating its regulatory and factual accuracy. We call this solution “rubbish in – rubbish out.” By using such a solution, the manufacturer exposes themself to the risk of significant recurring penalties for publishing defective data. In other cases, the tool did not allow for subsequent management and updates of already registered data. Even when the offered solution gave the impression of a reputable service, it was always difficult for domestic manufacturers to afford due to its high price.

That is why, in early 2025, we decided to develop, test, and commercially launch our own solution in the form of a sophisticated service called EUDAPORT, which includes a user-friendly method of collecting data for registration, supplementing it with other necessary information, conducting regulatory checks and technical verification, conversion into a file format enabling automatic upload, and finally, the actual upload to the EUDAMED database. We offer this entire solution at an affordable price, even from the perspective of a manufacturer based in the Czech Republic. We will also provide additional significant financial benefits to all regular Porta Medica customers.

More about the EUDAPORT service

Who is it aiming at?

·       Czech as well as foreign manufacturers of medical devices and IVDs

What does the service "bring to the table" for our customers?

·       Fast and user-friendly format of preparation, verification and bulk uploading data to the EUDAMED database as part of the mandatory registration of all medical devices and IVDs

What can you avoid thanks to the EUDAPORT service?

·       manually entering approximately 50 data points for each variant of every individual medical device or IVD in your portfolio, without the ability to clone, copy, or pre-fill data that has already been entered

·       misunderstanding which data fields are relevant and mandatory in your case

·       technical difficulties during unsuccessful attempts at bulk data uploads

·       penalties for publishing incomplete or incorrect data

·       disputes with customers resulting from the publication of incorrect data

·       problems when needing to bulk update already published data

What specific components does the EUDAPORT service include?

·       Individual preparation of a pre-programmed input form in MS Excel, where the manufacturer's employee can easily fill in and then automatically copy the minimum necessary amount of data for the purposes of registering the entire portfolio of products

·       In-person or telephone assistance with any difficulties or questions related to filling out the input form

·       Regulatory check of the filled-in data and supplementation of additional data required for registration

·       Technical validation confirming that the final file can be uploaded to the EUDAMED database

·       Conversion of data into .xml format

·       Bulk upload of data to the EUDAMED database

·       Support in the event of any necessary changes to already published data for registered devices

How much does the EUDAPORT service cost?

·       Pricing depends on the breadth of a particular provider’s portfolio

·       We offer both one-time service use and long-term, discounted subscriptions (clients receive a discount while spreading the one-time cost out over several smaller payments)

·       Long-term customers of Porta Medica and Porta Medica Legal also receive a loyalty discount

If you are interested in the EUDAPORT service and would like assistance with registering your products in the EUDAMED database, please do not hesitate to contact us at:

eudaport@portamedica.cz