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.
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 ...
February 18, 2022

Steps and timing to transfer your UK Responsible Person

Is it possible to transfer your UKRP? Can I appoint more than one UKRP? Is a Transfer Agreement needed between ...
January 31, 2022

How to Find GMDN Codes for Free

Need a GMDN code? Find here the three best ways to find GMDN codes for free. Plus, how to confirm that you selected the correct code & other GMDN FAQs.
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.