If you are a non-EU manufacturer of medical devices you need to comply with the Medical Device Regulation (MDR). The Regulation states manufacturers must select an importer that will have to meet the requirements and will be liable and responsible for placing products on the EU market.
By having one MDR/IVDR compliant independent medical device import partner, you avoid risks, eliminate administrative burden and market conflicts of designating (multiple) distributors as your importer.
Our turnkey solutions will offer complete efficient importing services.
We provide regulatory compliant importing, PRRC services, VAT and tax reclaim, and global sales development services.
With decades of expertise in regulatory and market development services in Europe, you partner with an ISO 13485 certified dedicated organization bringing knowledge, a fast, compliant and smooth onboarding for your importing needs.