UDI Registration in Swissdamed: Key Insights and Deadlines
With economic operator registration in the Actor module of Swissmedic’s Swissdamed database in force for Swiss…
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Top Errors When Importing Medical Devices into Switzerland
In regard to importing medical devices into Switzerland under the former Mutual Recognition Agreement (MRA) with the European Union –…
Swiss Economic Operator Vigilance Requirements Under IvDO
With the establishment of…
Swiss Economic Operator Vigilance Requirements Under MedDO
With the establishment of…
Integrating Swiss MedDO and IvDO into your QMS
Despite the Swiss Medical Devices Ordinance 812.213 (MedDO) having entered into force on May 25, 2021, and In Vitro…
Swiss IvDO: Fast-Approaching Deadlines for IVD Manufacturers
As we’ve previously reported for non-IVD devices, under the new Swiss Medical Devices Ordinance…
EU MDR
Swiss Importer
EU IVDR
EU Importer
General
UK Responsible Person
UK Importer
Swiss Authorized Representative
Consolidating Authorized Representative and Importer Roles Pros and Cons
In this article, we share the advantages and disadvantages associated with consolidating the roles of authorized representative and importer.
Responsibilities of a SaMD Importer
As we’ve noted in a previous article, under the EU Medical Device Regulation (MDR) 2017/745 and…
Swissmedic: How Medical Device Regulation Has Changed
Swissmedic has implemented new requirements for manufacturers to continue selling medical devices in Switzerland which we will explore below. But…
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