Non-EU manufacturers can sell medical devices on the European Union market only if they appoint an authorised representative (EAR). Read more!
Medical devices and healthcare
What is a PLIP and why is it required under MDR?
Article 10 (16) of the MDR obliges the manufacturer to have sufficient financial coverage for potential liability of defective medical devices. Read more!
What documents are required for EUDAMED Actor Registration?
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.
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 IVDR (Regulation on in-vitro diagnostic devices) applies as of May 26, 2022, profoundly…
5 things to know about EUDAMED registration
Covering the whole European Union, EUDAMED (European database for medical devices) is the European Commission’s…
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!