The UK has updated its guidance on the UK Responsible Person. The document is applicable should the UK leave the EU without a deal and includes important details about the… Read More
New Guidance for the UK Responsible Person Published
Month: September 2019
Stop your Confusion about CE Marking – read our FAQ
What is CE Marking? Why do I need a European Authorized Representative? What is a Free Sales Certificate? Manufacturers, im- or exporters and distributors of medical devices find brief answers… Read More
Don’t Search No More, For Your EU Authorized Representative
Finding your EU Authorized Representative* is like finding the love of your life. Pity is, you already might have found the right one, but you just can’t believe your luck.… Read More
All About Brexit – But We’re Not Clairvoyant
Brexit or no Brexit? Deal or no deal? As long as the British Government is not in harmony with itself the story of “in or out” will keep the world… Read More
CE Marking Made Easy, Like a Day at the Beach
Of course, CE Marking is complicated. If you are a manufacturer, an im- or exporter or a distributor, your key competence probably centers more around engineering, sales or organizing endless… Read More
News from the Commission – Notified Bodies and a Potential MDR Extension for Selected Devices
Many important documents and guidance for the implementation of Regulation (EU) 2017/745 on medical devices (MDR) are still missing. In certain aspects, however, things seem to evolve in a direction… Read More