December 18, 2023

UK MHRA Medical Device & IVD Registration: Step-by-Step Guide

Step-by-step guide on how to register medical devices & IVDs with the UK MHRA. Includes necessary links and screen-shots to walk you through the process.
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 […]
April 28, 2023

UK MHRA: MORE Vigilance Platform, New Account Creation Guide

Find out how to register in the UK MHRA's new MORE vigilance platform. The page includes the steps, templates, e-mail addresses and deadlines to comply.
February 20, 2023

Is There Any Advantage to UKCA Marking Early?

Most will make use of the UKCA delay & CE Marking transition period. However, there is an advantage to UKCA Marking for some low-risk devices. Find out why.
October 18, 2022

UKCA Marking: Fact Sheet for Medical Devices & IVDs

Read our Fact Sheet to find out: UKCA Marking deadlines; UKCA versus CE Marking technical file and labeling differences; where to download the symbol; and more.
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 ...
March 1, 2022

Northern Ireland Medical Device Requirements

Northern Ireland has one foot in the UK door and one foot in the EU door. Find out what is really needed to sell your medical devices in Northern Ireland.