Eurofins Medical Device Services' global network supports market access worldwide by addressing applicable regulatory frameworks, standards, and regional requirements.

We support compliance and market entry across a wide range of regions, including:

  • European Union: Medical Device Regulation (MDR)
  • European countries outside the EU
  • United States: FDA Regulation (21CFR 820)
  • LATAM (Latin America), APAC (Asia-Pacific), Australia, Japan, and additional global markets

Navigate global market access with confidence