UDI and product records
Connect Basic UDI-DI, UDI-DI, product families, markets and documents to the technical product structure. Assign clear responsibility for maintenance and approval.
RIM / REGULATORY INFORMATION
Regulatory information. Clearly connected.
When product data, evidence and approval statuses are managed separately, every change requires coordination. A shared information structure makes relationships and responsibilities visible.
Discuss your projectWHAT MATTERS
Dossiers, changes and deadlines
Bring authorisation status, evidence and tasks together in RIM. Make Aras changes and their effects on product information and registration data traceable.
swissdamed, EUDAMED and GUDID
Structure and check data for the relevant registries. Consider MDR/IVDR, Swiss MedDO/IvDO and US UDI requirements separately. Transfer methods are agreed for each target system.
REGULATORY / CH & EU
swissdamed: clarify data and responsibilities
Updated: 9 September 2026 · Editorial team: VALNARO AG
swissdamed
Product registration has been mandatory since 1 July 2026, with transition ending on 31 December 2026. Certain vigilance reports trigger immediate registration. The device case and economic operator role matter.
EUDAMED
The first four modules have been mandatory since 28 May 2026. For certain previously marketed devices, the EU timeline gives 28 November 2026 as the registration deadline. New devices and certificates have separate rules.
Responsibilities before interfaces
Review UDI and actor data, mandates and approvals together. Registration in EUDAMED does not replace registration in swissdamed. MDR/IVDR and the Swiss MedDO/IvDO are distinct legal frameworks.
This information provides orientation and does not replace legal or regulatory advice. Applicability, transitional provisions and obligations must be checked for each product.
These pages present the RIM, PIM and DPP solutions from mediatec.net. Product views illustrate workflows and data structures; we work with you to define usage and the scope of delivery for your company.
INSIDE THE PRODUCT
From data model to daily work.
Product views from mediatec.net. Demo data; displayed figures and dates are neither customer references nor regulatory guidance.
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