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
Accredited Medical Device Testing
We meet the highest international standards for both regulatory safety studies and laboratory competence.
Hohenstein Medical is a GLP-certified and ISO/IEC 17025-accredited laboratory for medical devices. Our work supports manufacturers with regulatory studies, product validation and performance evaluations grounded in international standards and scientific integrity.
Testing Capabilities Include:
- Chemical characterization and substance screening (e.g. extractables, leachables, residuals)
- In vitro biological safety testing (e.g. cytotoxicity, irritation, sensitization)
- Microbiological evaluations (e.g. bioburden, antimicrobial efficacy, barrier performance)
- Surface analysis (e.g. contamination, degradation, wear under simulated use)
- Shelf life and aging studies (e.g. accelerated aging, packaging durability, reprocessing effects)
- Disinfectant testing (e.g. material compatibility, performance impact)
- Performance assessments (e.g. compression, strength, durability)
- Comfort & useability testing (e.g. skin and microclimate, breathability, thermal insulation)
- Odor testing (perspiration, urine and wound)
- Fit and Pattern (pattern development, fit testing, body measurement data, 3D/4D scanning)
- Technical documentation and GLP-compliant reporting for regulatory submission
- Custom test development aligned to product function and regulatory needs
We test single-use and reusable products, finished devices and components, patient-contact materials and protective equipment—tailored to the intended use, contact classification and regulatory pathway.
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
Accreditations
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
Trusted by Regulators and Medical Device Companies
What our accrediations mean for you
ISO/IEC 17025:
Trusted, Recognized Testing for Regulatory Submissions
- Compliance with international laboratory quality standards
- Validated, repeatable results using standardized test methods
- Full traceability and quality-controlled documentation
- Testing performed by qualified personnel using calibrated equipment
- Recognition of test results by regulatory bodies worldwide (including FDA and EU authorities)
- Reduced risk of repeat testing or regulatory rejection
- Faster approval processes for 510(k), MDR and other submissions
GLP-compliant Testing (Good Laboratory Practice):
Reliable Study Design and Standardized Safety Data
- Reliability, reproducibility and regulatory confidence for non-clinical health and environmental safety studies
- Global comparability and acceptance of safety data and test results
- Quality assurance, traceability and regulatory compliance across personnel, facilities, materials, reporting and data archiving
- Strict requirements for study planning, execution and reporting
- Required for medical devices with biocompatibility or chemical exposure
- Data integrity requirements for FDA 510(k) and MDR Annex I/II submissions
- Toxicological risk assessment support under ISO 10993
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