European Union · Biocompatibility under MDR
European Union · Biocompatibility under MDR
We produce a risk-based Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) aligned to ISO 10993-1 and MDR Annex I §10, integrating—where available—chemical characterization (ISO 10993-18) and toxicological risk assessment (ISO 10993-17). The outcome: a clear, Notified-Body-ready biological evaluation that justifies biological safety for your device under MDR.
Risk-based BEP & BER
Annex I §10 alignment
10993-18 & 10993-17 integration
NB-ready justification
How we build your MDR biocompatibility narrative
This service is for foreign device manufacturers who are already in FDA’s system and want to make sure the right U.S.-based contact is on record.
- Collect docs → Intended purpose, materials, contact, existing test/TRA/chem-char.
- Draft BEP → Device/contact mapping, biological effects and evidence plan.
- Compile & justify → Integrate chem-char and TRA; document uncertainties and NA areas.
- BER & handover → Final risk-based conclusions, evidence map, and change log.
What You Will Receive
BEP: Risk-Based Biological Evaluation Plan
- Device category and contact mapping based on intended purpose, tissues, and contact duration.
- Biological effects table reflecting ISO 10993-1’s effects-based view, tailored to your device.
- Evidence plan: which existing tests, literature, and clinical data are relied on; where 10993-18 and 10993-17 inputs are expected.
- Acceptance criteria and decision logic that connect ISO 10993-1 to MDR Annex I §10 requirements.
BER: Biological Evaluation Report
- Structured risk-based conclusions for each relevant biological effect and contact scenario.
- Clear treatment of uncertainties, limitations, and residual risks.
- Explicit references to chemical characterization (ISO 10993-18) and toxicological risk assessment outcomes (ISO 10993-17) where you provide them.
- MDR Annex I §10 framing, showing how the evidence supports conformity for chemical, physical, and biological properties.
Evidence Map & Change Log
- Cross-references from BEP/BER statements to reports, literature, and standards (IDs, sections, filenames).
- Visibility of gaps: items that need strengthening or follow-up before/around Notified Body review.
- Concise change log to track updates due to new data or standard revisions (e.g., 10993-1/-17/-18 updates).
Consulting & documentation only. No laboratory testing; we are not a Notified Body. We integrate your laboratory outputs and existing reports where applicable.
Why Teams Choose Sobel for Independent ISO 10993-1 Gap Reviews
Sobel acts as a critical, precise external reader for your biological evaluation documentation—focusing on how reviewers interpret your files, not on selling generic tools.
- Independent perspective on how your dossiers align with the ISO 10993-1:2025 biological effects view and ISO 14971-style risk estimation.
- Tight focus on one outcome: a concise, prioritized gap report—not templates, scorecards, or ready-made drafts.
- Strong emphasis on how chemistry (ISO 10993-18) and toxicological risk assessment (TRA, ISO 10993-17:2023) support sufficiency judgments.
- Clear explanations of where rationales are robust, weak, or missing, written in reviewer-oriented language.
- Experience across multiple markets (EU, FDA, Brazil and others), reflecting how authorities frame ISO 10993-1 within the broader risk-management process.
Our process
e turn the DRLM update and 10-day confirmation into a controlled mini-project.
Discovery
- Clarify intended purpose and claims, device classification, materials, and patient contact duration.
- Review available chemical characterization (ISO 10993-18), toxicological risk assessment work (ISO 10993-17), historical biocomp tests, literature, and applied standards.
Build the BEP
- Define device/contact category and associated biological effects based on ISO 10993-1.
- Document the evidence plan, acceptance criteria, and how the evaluation will speak to MDR Annex I §10.
Compile & justify
- Integrate your chem-char and TRA inputs where provided; align conclusions with ISO 14971-style risk thinking.
- Document uncertainties, NA decisions, and any gaps in a way that is transparent for Notified Bodies.
BER & handover
- Produce the BER with risk-based conclusions, Annex I §10 alignment, and explicit links to ISO 10993-18 and -17 evidence.
- Deliver the evidence map and change log so your team can maintain the evaluation over time and across submissions.
What We Need From You
- Intended purpose and claims for the device, including target patient groups and use conditions.
- Materials, component overview, and patient contact category and duration.
- Available chemical characterization reports (ISO 10993-18) and toxicological risk assessment materials (ISO 10993-17).
- Historical biocompatibility testing, clinical data, and relevant literature you want considered.
- List of applied standards and guidance documents you follow.
- Any existing Notified Body feedback related to biocompatibility or Annex I §10.
Consulting and documentation service only. We produce the BEP and BER, map your existing evidence, justify NA decisions, and highlight gaps. We do not perform laboratory testing, do not author label artwork, and do not act as a Notified Body. Your team owns testing decisions, laboratory contracts, and final submissions to authorities and Notified Bodies.
FREQUENTLY ASKED QUESTIONS
Not necessarily. ISO 10993-1 and MDR Annex I §10 expect a risk-based evaluation, not automatic testing. We start from your existing data (tests, TRA, chem-char, literature, clinical experience) and identify where the evidence is sufficient and where additional work may be justified. We do not run tests ourselves.
Where you provide 10993-18 and 10993-17 outputs, we integrate them directly into the evaluation logic: chemical identification and exposure estimates from 10993-18 feed the toxicological reasoning in 10993-17, which then supports the biological safety conclusions in the BER. The BEP clarifies this flow; the BER documents how these components support Annex I §10.
A GSPR matrix maps all Annex I General Safety and Performance Requirements clause-by-clause across your Technical Documentation. This service is narrower: it focuses specifically on the biological evaluation narrative (BEP/BER) under ISO 10993-1 and MDR Annex I §10. It complements, but does not replace, a full Annex I GSPR traceability matrix.
Yes. You can update your U.S. Agent on the Annual Registration review page during the Oct 1–Dec 31 annual registration window. Many companies combine agent changes with their yearly review.
The change affects where FDA sends communications and inspection scheduling notices, not the underlying device listings or marketing authorizations. Those remain in place as long as your registration and listing are current.
Keep FDA Communications Flowing to the Right U.S. Agent
If you are preparing MDR Technical Documentation and Annex I §10 feels fragmented across tests, TRA files, and chemical reports, a structured BEP and BER can bring it together into a single, defendable biological evaluation. We map your evidence, apply risk-based logic, and deliver an NB-ready narrative for EU biocompatibility.
Contact Us
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