In addition to EU-wide EUDAMED registration, some EU Member States require national registration of medical devices and in vitro diagnostic devices (IVDs) before they can be marketed. At EUmAccess GmbH, we help manufacturers, importers, and EU Authorized Representatives navigate the national registration process, ensuring full compliance with country-specific requirements
Why is National Registration Required?
Although EUDAMED is designed to centralize device registration, some EU countries still mandate additional national registrations until the database becomes fully operational. These regulations vary across different Member States and may require:
- Submission of device details to national health authorities
- Registration with local Competent Authorities (CA)
- Notification of changes in product status
- Additional documentation & fees depending on the country
Our National Registration Services
Country-Specific Registrations
We assist with national medical device registration in key EU countries that currently require independent registration, such as:
- Italy (Ministero della Salute)
- Spain (AEMPS)
- France (ANSM)
- Belgium (FAMHP)
- Portugal (INFARMED)
- Denmark (Danish Medicines Agency)
- Austria (BASG)
- Sweden (Medical Products Agency)
- Germany (BfArM)
Registration Process & Documentation Support
We ensure compliance with national regulatory requirements by:
- Preparing & submitting applications to Competent Authorities
- Ensuring compliance with MDR (2017/745) & IVDR (2017/746)
- Managing technical documentation & translations if required
- Coordinating with local regulatory bodies for approvals
- Updating registrations when required
Who Needs National Registration?
Medical Device & IVD Manufacturers seeking EU market access
Non-EU Manufacturers placing devices on the EU market
Importers & Distributors needing regulatory approval
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.