Build a Solid MDR Biocompatibility Package, With Clear Linkage to
Annex I GSPRs
A clean narrative and a clear matrix mean fewer questions and a stronger submission. We evaluate your device’s materials, chemistry, and biological risks using ISO 10993-1 principles — then map these conclusions to the EU MDR General Safety and Performance Requirements.
When Biological Evidence Creates Uncertainty
- You’re preparing your first MDR submission and need a complete ISO 10993-1 biological evaluation
- Your legacy MDD file lacks the narrative and risk logic expected under MDR
- You must determine which biological effects apply based on contact type and duration
- You need to justify testing, avoid over-testing, or align materials/chemistry evidence
- Your Notified Body is requesting clearer rationale, applicability, or biological evidence
- You need a clean pathway from biocomp → Annex I (GSPRs)
The MDR Expectations for Biological Safety
ISO 10993-1 positions biological evaluation within a risk-management process. Under MDR, this approach is essential to demonstrate material safety, biological compatibility, and traceable justification for each biological effect.
Annex I §10 makes biological, chemical, and physical properties explicit obligations.
Your device must show:
Materials are safe for the intended body contact
Chemical and particulate risks are understood
Biological effects are assessed and justified
Testing is proposed only when needed based on risk
A structured evaluation avoids unnecessary testing, accelerates technical reviews, and ensures biological safety aligns with MDR expectations.
How We Build Your MDR Biocompatibility Package
We start with ISO 10993-1 risk logic and then connect the outcomes to Annex I requirements — especially §10. The work is evidence-first, test-later.
We confirm contact type, duration, intended purpose, and materials/chemistry already available.
These elements define which biological effects apply.
We identify relevant biological endpoints using ISO 10993-1 logic and map the existing evidence (materials data, chemistry, literature, historical testing).
We propose laboratory tests only when required to close gaps. Unnecessary testing is avoided through justification based on risk.
We map your materials, chemistry, and biological conclusions to Annex I — especially §10 — creating a traceable line of evidence aligned with MDR expectations.
You receive a structured narrative, matrix, and Q&A notes anticipating Notified Body questions.
Deliverables That Strengthen Your MDR Submission
Your MDR Biocompatibility Package includes:
Why Teams Trust Sobel’s MDR Biocompatibility Work
Sobel supports global manufacturers with MDR submissions grounded in risk logic, evidence clarity, and regulatory traceability.
Our approach delivers:
ISO 10993-1 biological evaluation aligned with MDR expectations
Annex I mapping that demonstrates safety without over-testing
Traceable rationale from materials → evidence → conclusions
Fewer NB questions through clear documentation
Consistent application of risk-based evaluation across topics
Structured outputs aligned with Annex II and reviewer workflows
Build a Biocompatibility Package That Withstands MDR Review
Our team develops a complete ISO 10993-1 biological evaluation supported by materials and chemistry evidence — then connects it to Annex I for a clean, defensible MDR submission.
Contact Us
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