Our Services

As an EU Importer

As your official EU Importer, we:

Verify that your devices meet all IVDR requirements before entering the EU market.
Ensure proper labeling, instructions for use, and documentation in compliance with EU standards.
Act as the primary point of contact for EU authorities and notified bodies.

Language and Labeling Compliance

Ensuring device labeling and instructions for use are available in the required national languages of EU Member States.
Verifying that all information is clear, accurate, and compliant with IVDR standards.

Why Choose MD&D Alliance GmbH?

Regulatory Expertise: I stay updated with the latest IVDR requirements to ensure your devices meet every standard.
Comprehensive Services: From pre-market preparation to post-market surveillance, we handle all aspects of IVDR compliance.
Reliable Partner: dedicated team ensures your business operates smoothly in the EU market.