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Regulatory Consulting: Support in registering on the EUDAMED database

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: 468c7ed7-87aa-42c3-b7a9-eaa15c626a4f

Service Description

The European database on medical devices (EUDAMED) improves transparency and coordination of information regarding medical devices available in the European market. The database consists of 6 modules, and IPN can assist organizations in using the modules already available, that is, in the registration of manufacturers, importers, and authorized representatives in the Actor Registration Module with the issue of the “Single Registration Number” (SRN), and in the device registration in the “UDI/Device Registration Module”

Offerings: Ethics & Regulatory Affairs Quality Management Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Development of conformity evaluation standards, protocols & tools
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Country Portugal
Published Email medicaldevices@ipn.pt

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Certification Support CE Marking (MDR, IVDR)