EU Medical Device Regulation (MDR) Requirements
- Conformity assessments for devices based on risk class
- Technical files with GLP-compliant biological safety data
- CE marking prior to market placement
Meet regulatory requirements for medical devices.
Products claiming safety or performance features may be considered a medical device—and that brings specific regulatory responsibilities.
US FDA
EU MDR
Expert Insights
U.S. Food and Drug Administration (FDA) Requirements
- Product classification
- GLP-compliant safety data for body-contacting materials
- 510(k) submission or other approval pathway may be required
EU Regulatory Affairs Blog
Articles by Hohenstein and our partner, seleon, on medical device approval.
- ISO 18562 standard series – Biocompatibility evaluation of breathing gas pathways in healthcare applications
- Testing for cytotoxicity: The “well-established” EN ISO 10993-5
- Tests for irritation: The EN ISO 10993-23 extends the series of standards
- MDR requirements for medical devices also apply to compression stockings
- Blurb! What is that?
- Post-pandemic masks