One aspect of EU market access for medical devices that is often overlooked during regulatory strategy development and market access planning is national notification requirements and submissions to national databases.
Many manufacturers assume that obtaining CE marking under MDR or IVDR and completing EUDAMED registration automatically means their device can be made available throughout the EU. However, depending on the target markets, additional national obligations may still apply.
With the mandatory use of key EUDAMED modules from 28 May 2026, the EU is taking a major step towards harmonization. Nevertheless, manufacturers should not assume that EUDAMED will become the only platform through which information must be submitted to authorities. Depending on the target market, additional notifications or database submissions may still be required.
In practice, we have not encountered any two countries with completely identical requirements. Many Member States have established their own procedures, databases, timelines, and fee structures, creating a diverse landscape of country-specific obligations.
Requirements may depend on the economic operators established in a particular Member State, device classification, specific product categories, and even the distribution model used for placing devices on the market.
The nature of these obligations also differs significantly. Some Member States require action before a device is placed on the market, while others allow notification after commercialization. In some countries, compliance may be as simple as submitting information by email or completing a notification form. In others, manufacturers must interact with dedicated databases and online portals.
The administrative burden associated with such databases and portals can also vary considerably. Some systems allow submissions without prior account creation, while others require registration and various access authorization mechanisms.
Costs vary as well. While in some countries these procedures are free of charge, in others they may involve device notification or distributor registration fees. Depending on the country, additional annual fees or contributions may also apply.
Additionally, national obligations often extend beyond the initial submission, requiring manufacturers to keep information up to date and notify authorities of changes affecting the submitted data.
For manufacturers targeting multiple EU markets, coordinating these activities through numerous local parties can quickly become resource-intensive and difficult to manage consistently.
At Starodub, we support manufacturers with the planning and execution of national notification and database submission activities across multiple European markets. To learn more or discuss how we can support your team, please contact us at [email protected].
