Importing Medical Devices - A Complete Guide

The European medical device (MD) market is estimated to be worth around €140 billion. It is the second biggest 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 to consider exporting their products to the European Union (EU). Medical device importer are divided into four classifications (Class I, Class IIa, Class IIb, and Class III) based on risk and intended use—the higher the risk, the higher the Class.

We provide non-EU medical and in-vitro device manufacturers with independent European-wide importing services compliant with Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) requirements.

Import your medical goods Into Europe with our hassle-free market access Importing service while maintaining flexibility, compliance and Increased quality standards. With over 30 years of combined experience, GrowthImports is dedicated to ensure the facilitation of a compliant and smooth international MDR/IVDR compliant importing process in the European market. The EU comprises 31 countries and 23 official languages. Labeling of MDs, instructions for use, and documentation must be done in the Member State’s official language. The translation should comply with national regulatory requirements.

Medical device manufacturers must have a Quality Management System (QMS) in accordance with Annex II or V of the Medical Devices Directive (MDD). QMS compliance is based on ISO 13485, which specifies requirements for an organization to demonstrate its ability to manufacture medical devices that meet customer and regulatory requirements.