EU MDR / IVDR Requirements for Medical Device Repackaging and Relabeling in Europe
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 for Medical Device Repackaging and Relabeling This post discusses the basics of the European Union (EU) Medical Device Regulation (MDR) and In Vitro […]
Shipping Medical Devices to Europe: What to Consider.
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 United States. This should be encouraging to medical device companies that are considering exporting their products to the European Union (EU). What should MD […]
Medical Device Regulations Extended By EU
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 MDR and IVDR deadlines. This decision comes as a result of concerns surrounding disruptions to medical device supplies. Such concerns exist not only […]
Can a Medical Device Distributor in Europe Be an MDR/IVDR Importer?
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 and partner with representatives to do business within the EU. The importer is responsible for placing products into the EU, while the distributor […]
MDR Deadlines: Important Updates from the European Commission
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 certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen […]
Meet us at Arab Health 2023 Exhibition!
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 your Global Growth and Importing Opportunities in Europe and the Middle East! For more information – you can check our cases on GrowthImports […]
Advertising Medical Devices in the EU: Important Guidelines to Follow
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
VAT on Medical Devices in the EU
VAT in the EU can be complicated for some: While all VAT guidelines are set at the European Union level, member countries are allowed to
GrowthImports obtains ISO 13485:2016
GrowthImports obtains ISO 13485:2016. We’re very proud to announce we have been successfully audited for ISO 13485:2016. We are thankful for the great efforts of our team.
Welcoming Mrs. Elvan Inkaya
We are excited to announce Elvan Inkaya has joined GrowthImports as our new quality assurance director.