Database Registration Services
Product Registration & Database Submissions
We handle all required database registrations for your medical devices, IVDs, and cosmetics across Europe - EUDAMED, UK PARD, Swissdamed, national databases, CPNP, and UK SCPN.
- EUDAMED: UDI/Device registration with bulk uploads
- UK PARD (MHRA) & Swissmedic registration
- National EU databases where required
- CPNP & UK SCPN for cosmetics
On this page
Database Registration: An Overview
Placing medical devices, IVDs, or cosmetics on the European market requires registration in various databases. These registrations are mandatory legal requirements - not optional administrative tasks.
As your Authorised Representative (EU-REP/ CH-REP), UK Responsible Person, or Responsible Person for cosmetics, we handle all required database submissions on your behalf. This includes initial registrations, updates, and ongoing maintenance.
Key databases we work with:
Medical Devices & IVDs:
- EUDAMED – EU database for medical devices and IVDs (MDR/IVDR)
- UK PARD – MHRA Product and Registration Database for Great Britain
- Swissdamed – Swiss Database on medical devices
- National EU databases – Country-specific requirements (e.g. Italy, etc.)
Cosmetics:
- CPNP – Cosmetic Products Notification Portal (EU)
- UK SCPN – Submit Cosmetic Product Notification (Great Britain)
EUDAMED: The EU Database for Medical Devices
UDI Submission & Device Registration
EUDAMED is the European database for medical devices and IVDs under the MDR and IVDR. It consists of several interconnected modules that serve different purposes.
EUDAMED Modules & Our Services
We handle the following EUDAMED registrations:
UDI/Device Registration: Submission of device data including Basic UDI-DI, UDI-DI, and all required device attributes. We support both individual submissions and bulk uploads.
Bulk Uploads: For manufacturers with large product portfolios, we perform bulk uploads using structured XML files to efficiently register hundreds or thousands of devices.
Updates to device data, new versions, discontinuations, and verifications as required.
UDI Compliance: EUDAMED registration requires complete UDI data. We work with your UDI data (from GS1, HIBCC, ICCBBA, or IFA) to ensure accurate and compliant submissions. We do NOT issue UDIs - this is the manufacturer's responsibility.
National Databases: Where EUDAMED Is Not Enough
Country-specific registration requirements
While EUDAMED is the central EU database, several member states maintain additional national databases that require separate registration. These national requirements exist alongside EUDAMED, not as alternatives.
Countries with Additional Database Requirements
Examples of national databases we handle:
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.
National database requirements change frequently. We monitor regulatory developments across all EU member states and inform you of any new registration obligations affecting your products.
UK PARD: Product and Registration Database (MHRA)
Mandatory registration for medical devices in Great Britain
Since Brexit, medical devices placed on the Great Britain market (England, Scotland, Wales) must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) through the Product and Registration Database (PARD).
This is separate from EUDAMED and applies to all medical devices, including IVDs, that are placed on the GB market.
UK PARD Registration Services
As your UK Responsible Person, we handle:
Device Registration: Registration of all medical devices and IVDs in the MHRA database before placing them on the GB market.
Manufacturer Registration: Registration of non-UK manufacturers with the MHRA.
UK Responsible Person Registration: Registration of ourselves as your UKRP with the MHRA.
Device Changes: Updates to registrations when device details, classifications, or other information changes.
UK Registration Requirements
Who must register:
- All manufacturers placing devices on the GB market
- UK Responsible Persons acting on behalf of non-UK manufacturers
- Devices of all risk classes (Class I, IIa, IIb, III, and all IVD classes)
Timeline: Devices must be registered with the MHRA before being placed on the GB market. Registration fees apply and vary by device class and number of devices.
Note: Northern Ireland follows EU rules (EUDAMED), not UK PARD. Devices sold in both GB and NI may require registration in both systems.
Swissdamed: Swiss Medical Device Registration
Mandatory registration for medical devices in Switzerland
Medical devices placed on the Swiss market must be registered with Swissmedic, the Swiss Agency for Therapeutic Products. Switzerland has aligned its medical device regulations with the EU MDR and IVDR through the revised Swiss Medical Devices Ordinance (MedDO/IvDO).
Swissdamed Registration Services
Through our Swiss partner network, we handle:
Device Notification: Registration of medical devices and IVDs in the Swissmedic database.
Maintenance: Updates to registrations when device information changes.
Regulatory Monitoring: Tracking of Swiss regulatory developments and new requirements.
If you sell in both the EU and Switzerland, you need registrations in both EUDAMED and Swissmedic. We can coordinate both registrations to ensure consistency and compliance.
CPNP: EU Cosmetic Products Notification Portal
Mandatory notification for cosmetics in the EU
Under EC 1223/2009, all cosmetic products placed on the EU market must be notified in the Cosmetic Products Notification Portal (CPNP) before market placement. This notification is the obligation of the Responsible Person.
CPNP Notification Services
As your Responsible Person, we handle:
Initial Product Notification: Registration of new cosmetic products with all required data (product category, frame formulation, labelling, etc.).
Product Updates: Modifications to existing notifications when formulations, labelling, or other details change.
Nanomaterial Notifications: Specific notifications required for products containing nanomaterials (6-month advance notification).
CMR Substance Notifications: Notifications for products containing CMR substances under specific conditions.
UK SCPN: Submit Cosmetic Product Notification
Mandatory notification for cosmetics in Great Britain
Since Brexit, cosmetic products sold in Great Britain (England, Scotland, Wales) must be notified separately in the UK Submit Cosmetic Product Notification (SCPN) system. This is independent of CPNP and requires a UK-based Responsible Person.
UK SCPN Notification Services
As your UK Responsible Person, we handle:
Product Notification: Registration of cosmetic products in the UK SCPN system before market placement in Great Britain.
Data Migration: For products previously notified via CPNP, we ensure proper notification in UK SCPN.
Updates: Maintenance of notifications when product details change.
Nanomaterial & CMR Notifications: Specific UK requirements for nanomaterials and CMR substances.
Northern Ireland: Products sold in Northern Ireland follow EU rules (CPNP), not UK SCPN. If you sell in both Great Britain and Northern Ireland, both notifications may be required.
Frequently Asked Questions
Common questions about database registration
Have more questions? Contact our team for clarification.
Need Help with Database Registrations?
Let's discuss your registration requirements across EUDAMED, national databases, and cosmetics portals.
We typically respond within 24 hours