Database Registration & Regulatory Submission Support
Placing regulated products on the European market may involve various regulatory database submissions and notification requirements depending on the product category, jurisdiction, and applicable regulatory framework.
Depending on the applicable scope and project requirements, Elpisia Europe provides practical support relating to selected regulatory database submissions, product registration coordination, and ongoing regulatory update activities.
Applicable Regulatory Databases & Systems
Medical Devices & IVDs
• EUDAMED-related support under MDR/IVDR frameworks
• Assistance with selected national registration requirements where applicable
• Product and regulatory documentation coordination support
Cosmetics & Personal Care Products
• CPNP-related notification support
• Regulatory documentation and compliance coordination assistance
EUDAMED Support
EUDAMED is the European database framework relating to medical devices and IVD products under MDR and IVDR. Depending on the applicable project scope, Elpisia Europe may assist with practical coordination relating to:
• Device and UDI-related registration support where applicable
• Coordination of structured submission activities for eligible product portfolios
• Regulatory update and registration maintenance support
• Assistance relating to applicable device data coordination processes
Manufacturers generally remain responsible for UDI issuance, product classification, technical documentation accuracy, and overall regulatory compliance.
National Registration Requirements
In addition to broader European regulatory frameworks, certain European jurisdictions may maintain additional national registration or notification requirements for specific product categories.
Depending on the applicable market and regulatory scope, Elpisia Europe may assist with practical coordination relating to selected national registration requirements and ongoing regulatory update monitoring activities.
Germany (DMIDS): The German Medical Devices Information and Database System.
Italy (NSIS): National device database with registration requirements.
Spain (CCPS): Registration in the Spanish medical device database.
Other EU Member States: Various countries have specific requirements that we monitor and support you to fulfil.
CPNP Notification Support
Applicable European cosmetic regulations generally require cosmetic products placed on the EU market to be notified through the Cosmetic Products Notification Portal (CPNP) before market placement.
Depending on the applicable product category, regulatory framework, and agreed project scope, Elpisia Europe may assist with practical coordination relating to CPNP notification and related compliance support activities for eligible cosmetic and personal care products.
• Assistance with initial CPNP-related notification processes
• Ongoing regulatory communication and compliance coordination support
• Assistance relating to applicable notification processes involving regulated substances where applicable
Frequently asked questions
1. Is EUDAMED registration required for medical devices and IVDs?
Yes, starting from the 28th of May 2026. All medical devices and IVDs placed on the EU market must be registered in EUDAMED. Specific timelines apply for legacy devices transitioning from the old directives.
2. Are national database registrations still required in addition to EUDAMED?
Depending on the applicable product category, target market, and local regulatory requirements, certain European countries may maintain additional national registration or notification requirements alongside broader European regulatory frameworks.
In some cases, registration or notification obligations at the national level may continue to apply even where broader European database submissions or registrations have been completed.
Applicable requirements may vary between jurisdictions and may change over time as European regulatory systems continue to evolve.
Elpisia Europe may assist with practical coordination relating to selected national registration requirements and ongoing regulatory update monitoring activities where applicable.
3. What is the Cosmetic Products Notification Portal (CPNP)?
CPNP is the European Union’s notification system relating to cosmetic products placed on the EU market under applicable European cosmetic regulations.
Elpisia Europe may assist with practical coordination relating to applicable CPNP notification processes for eligible cosmetic and personal care products.
4. Who is responsible for UDI management?
Manufacturers are generally responsible for obtaining applicable UDI identifiers from recognized issuing entities (GS1, HIBCC, ICCBBA, or IFA) and maintaining the accuracy of related device information and documentation.
Elpisia Europe may assist with practical coordination relating to applicable EUDAMED submission and registration support activities within the agreed project scope.
7. Can Elpisia Europe support registrations across Europe?
Elpisia Europe may assist with practical coordination relating to selected European regulatory database submissions and applicable national registration requirements depending on the product category, jurisdiction, and project scope.
Applicable regulatory requirements may vary between European countries and continue to evolve over time.
5. When do regulatory database registrations need to be updated?
Regulatory database submissions and product registration records may require updates when relevant product or company information changes, depending on the applicable regulatory framework and product category.
Elpisia Europe may assist with practical coordination relating to applicable registration maintenance and update activities where relevant.
6. Why are regulatory registrations and notifications important?
Applicable European regulations may require certain product registrations, notifications, or database submissions before products can be placed on the market.
Failure to fulfil applicable regulatory requirements may affect market access or trigger regulatory or market surveillance actions depending on the applicable jurisdiction and product category.
