Economic Operators and the CE Mark on Medical Devices If you’re a medical device manufacturer, supplier, or importer but aren’t knowledgeable about the European Union Medical Device Regulation (EU-MDR) and In Vitro
Companies exporting medical devices to the EU must comply with MDR labeling requirements, or they may face fines, sanctions, or lose access to the EU market. Labeling Requirements and Instructions for Use
The new MDR / IVDR requires specific and new labeling requirements for Medical Devices imported in Europe. We provide a summary of how devices entering the European market should be labelled. A
For medical device companies working with relabeling and repackaging, the new MDR and IVDR requirements can seem complex. This simple guide will help you ensure complete compliance. EU MDR / IVDR Requirements
The European medical device (MD) market is estimated to be worth around €140 billion. It is the second MD market in the world, covering 27.6% of the world market, behind only the
Recently, a significant development has come to pass concerning the implementation of the EU’s new medical device legislation. Last week, 16 February 2023, the European Commission shared its intent to extend the
There are four key players in the sale of medical devices (MDs) outside the European Union (EU): the manufacturer, authorized representative, importer, and a medical device distributor. Non-EU manufacturers create the devices
Proposal Pending at European Commission to Delay MDR Deadlines: More Time to Certify Medical Devices to Mitigate Risk of Shortages On January 6th 2023, The European Commission adopted a proposal to give more time to
Starting 2023 effectively! Our GrowthImports Team will be attending Arab Health Exhibition in Dubai from 30th January to 2nd February. We would be happy to meet you at the tradeshow and explore
The European Union has the second largest medical device market share in the world, worth €140 billion, which corresponds to 27.6% globally. The United States