Covering the whole European Union, EUDAMED (European database for medical devices) is the European Commission’s…
Medical devices and healthcare
Navigating Online Sales of Medical Devices in Europe: Regulatory Considerations
When venturing into online sales of medical devices and in vitro diagnostics (IVDs) in Europe,…
IVDR Compliance towards Korean/Chinese manufacturers
As an IVD (In Vitro Diagnostic) Korean manufacturer, accessing the EU (European Union) market can…
Webinar: (New)MDR Legacy extension: EU, UK and CH
Register to our new webinar to learn about the MDR Legacy extension in EU, UK and CH. Register now!
EU to have the world’s first comprehensive law on Artificial Intelligence by end of 2023
Discover the new GDPR obligations for businesses and organizations within the EU and UK!
Classification of medical device software in the European Union
Discover the new GDPR obligations for businesses and organizations within the EU and UK!
Products falling under the General Product Safety Directive (GPSD): compliance process with the new Regulation from 2024
On 23 May 2023 the Official Journal of the EU published a new law, the General Product Safety Regulation (GPSR). From 13 December 2024, manufacturers will have to comply with the new GPSR.
Webinar: Steps to enter the Australian market for Medical Devices
Manufacturers! Interested in the European Commission proposal for legacy devices? Our consultant will be offering an interpretation of the European Commission proposal for legacy devices regarding the following date: March 20, 2023
What is CE Marking?
A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.
Selling medical devices online in the EU
Complying with the rules on distance selling of medical devices and in vitro diagnostics device is a fundamental step when a manufacturer chooses to sell the devices online.