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.
VALNARO AG · SWITZERLAND
Medtech & life sciences
From engineering to market registration: product data must be consistent, changes traceable and responsibilities clear.
Before the UDI: engineering in Aras
Requirements, product structures, documents and changes form the engineering foundation. Aras PLM connects this information; the approved product configuration anchors downstream data.
From the UDI: regulatory work in RIM
Maintain Basic UDI-DI, UDI-DI, markets, evidence and registration status in product records. RIM workflows prepare data for swissdamed, EUDAMED and, for US market access, GUDID. Target systems and transfer methods are assessed in the project.
QA stays part of the process
Align document control, approvals and change assessment with your quality system, for example in the context of ISO 13485 and MDR/IVDR. System validation depends on intended use and risk; approval stays with the responsible specialists.
This information provides orientation and does not replace legal or regulatory advice. Applicability, transitional provisions and obligations must be checked for each product.
REGULATORY / CH & EU
swissdamed: clarify data and responsibilities
Updated: 9 September 2026 · Editorial team: VALNARO AG
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.
LET’S START A CONVERSATION