Regulatory Importer For Medical Devices
RegTrac provides seamless importer services to ensure your products meet EU regulatory standards, facilitating smooth market entry and ongoing compliance.
- Product Registration / Notification
- Communication Liaison with Regulatory Bodies
- Query Resolution with Health Authorities
- Verification of Technical Documentation
- Quarterly Reports with Regulatory Updates
- Continuous Product Compliance
Navigating the complexities of EU MDR/IVDR regulations can be challenging for MedTech manufacturers outside the EU.Under Article 13 of EU MDR / IVDR non EU manufacturers must appoint a Regulatory Importer ahead of placing the device products in EU market.
At RegTrac, we specialize in providing comprehensive Regulatory Importer services for medical device products including software medical devices (SaMD). From meeting importer requirements to collaborating with your EU Authorised Representative, we ensure full regulatory compliance.
Further, the Blue Guide on the implementation of the EU Product rules helps understand additional responsibilities applicable for importers in EU. Partnering with RegTrac helps streamline your compliance journey and accelerates your access to the EU market.
Key Responsibilities
Importer Plays a critical role for non EU manufacturers with regulatory compliance in placing the device product (individual shipments/batches) on the EU Market.
Article 13 of EU MDR / IVDR, Blue guide, Market surveillance regulations detail the key responsibilities applicable for importers in EU.
Confidently meet the EU regulatory requirements for Importers with RegTrac by your side—book your consultation today and unlock faster, smoother access to the European market.
Why choose us
Proven Importer Experience
RegTrac brings expert knowledge and hands-on experience navigating EU MDR/IVDR requirements.
Your Regulatory One Stop Shop
From EAR, EUDAMED registration & Importer support to vigilance reporting, we manage every product compliance with precision.
Dedicated Compliance Partner
We go beyond basic service—acting as a strategic partner committed to your long-term regulatory success.
Seamless Market Entry
We handle the full regulatory importer process so your medical devices can enter the EU market efficiently.
Not sure which solution fits your needs? Our regulatory experts offer a free 30-minute consultation to assess your product, target markets and compliance gaps — with no obligation and no sales pressure.