“On a duly justified request, Swissmedic may authorise the placing on the market and putting into service of a specific device the use of whi...
New MIR Form (Version 7.3.1)
The European Commission has published the updated Manufacturer Incident Report (MIR) PDF form, version 7.3.1, which will become mandatory on November ...
Swiss Federal Council to recognize FDA approvals / clearances — A game-changer for Medtech access!
In a landmark move, the Swiss Federal Council has decided to recognize approvals from the U.S. Food and Drug Administration (FDA), ensuring continued...
Important Updates on Swiss In-Vitro Diagnostics Ordinance!
On November 20, 2024, the Swiss Federal Council decided to align the In-Vitro Diagnostics Ordinance (IvDO) with the updated EU transition periods. Thi...
Integration of Mandates in Swissdamed!
The Swiss medical device database – swissdamed has gone live this month and actor registrations are open for Swiss entities. For foreign manufacture...
Swissmedic announces new Swissdamed Database!
Swissmedic is pleased to announce the launch of Swissdamed, a new database designed to support the implementation of Swiss regulations for medi...
Important News from Swiss Medtech for medical device Manufacturers, Importers and Distributors!
New guidelines have been released detailing the regulatory requirements for placing “legacy devices” on the Swiss market. This is essentia...
Revision of MedDO and IVDO
New requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and in vitro di...
Swiss Database on Medical Devices – swissdamed!
Swissmedic released a comprehensive guidance document for the implementation of the Swiss Database on Medical Devices – swissdamed. Feel fully...
The UK and Switzerland have embraced the EU MDR extension!
The EU currently leads the way in regulatory standards, with the UK and Switzerland following suit. This is being done for valid reasons, as medical d...
