June 9, 2023

Guide: Systems/Procedure Packs and Kits

Definitions: Systems, Procedure Packs, Kits Sytems and Procedure Packs MDR, Article 2(10): “‘procedure pack’ means a combination of products packaged together and placed on the market […]
February 8, 2023

Steps and timing to transfer your Swiss Authorized Representative (CH-REP)

Find out the steps and timing to transfer your Swiss Authorized Representative (CH-REP) for medical devices and IVDs.
August 4, 2022

Declaration of Conformity Requirements: EU, the UK and Switzerland

Find out how to create medical device Declarations of Conformity for Europe, the UK and Switzerland. Plus, Procedure Packs and Custom-made device statements.
May 17, 2022

‘Placing on the Market’: Definition and Cutoff Dates for EU, UK & Switzerland

Why does 'placing on the market' matter? EU definition of 'placing on the market' UK definition of 'placing on the ...
February 21, 2022

Labeling Requirements for the EU, UK and Switzerland In-Country Representative

Manufacturers selling in the EU, UK and Switzerland need to consider the different labeling requirements for listing their in-country representatives ...
January 18, 2022

What is a CHRN (Swiss Single Registration Number)?

Below is an overview of the Swiss Single Registration Number and how it applies to you. What is a Swiss ...
January 3, 2022

Certificates of Free Sales for Medical Devices

Do you need a European Free Sale Certificate for export, but not sure how to get one? Find out here who is allowed to request one, the cost and time.