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)
- Biological safety (in vitro) 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 accreditations 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
Additional Health- & Development-related Services
About Hohenstein Medical
For over 30 years, Hohenstein’s medical division has applied expertise in medicine, biomedicine, engineering and chemistry to deliver targeted testing for medical devices and materials.
We are an ISO/IEC 17025 accredited and GLP-certified laboratory helping companies bring safe, effective medical devices to market. Independent proof of safety and performance is essential to meet regulatory requirements worldwide, including FDA guidance and the European Medical Device Regulation (MDR).
We deliver this evidence through accredited testing, close collaboration with clients and customized study designs when standard methods are not sufficient. Global manufacturers rely on our independent testing and assessments to strengthen products and achieve regulatory approval.