October 24, 2023

EU Guide: Shelf Life, Expiration Date, Expected Lifetime/Useful Life, Service Life, Life Cycle

Overview of Shelf Life, Expiration Dates, Device Lifetime/Useful Life and Service Life for medical devices and IVDs in Europe.
June 9, 2023

EU, Swiss, UK Guide: Systems/Procedure Packs and Kits

Page Last Updated: 20 December 2023 Definitions: Systems, Procedure Packs, Kits Systems and Procedure Packs MDR, Article 2(10): “‘procedure pack’ means a combination of products packaged […]
February 8, 2023

Transfer your Swiss Authorized Representative (CH-REP): Steps and Timing

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: Europe, UK and Switzerland

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.