Articles 31 of the MDR and Article 28 of the IVDR require all manufacturers, authorised representatives, and importers to register as actors on the EUDAMED database.
Medical devices and healthcare
Reusable surgical instrument, a MDR legacy device?
The coming into effect of the MDR has meant several new changes for manufacturers. Among those, the MDR has set a new classification category for Class I devices: the reusable surgical instruments (Class Ir).
3 Tips to Obtain IVDR Certification
The EU In-Vitro Diagnostic Regulation (IVDR) has applied since May 26, 2022, significantly changing regulatory…
5 things to know about EUDAMED registration
Covering the whole European Union, EUDAMED (European database for medical devices) is the European Commission’s…
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!
General Product Safety Legislation: What’s Changing
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.