Biological Evaluation & Biocompatibility Testing for Medical Devices
We plan and manage your ISO 10993 biological evaluation end to end: material characterisation, Biological Evaluation Plan, chemical characterisation, testing in associated labs and a Biological Evaluation Report that satisfies Notified Bodies and the FDA.
What is biological evaluation?
Biological evaluation shows that the materials in your device are safe for the way they contact the body. It follows ISO 10993-1 and sits within your ISO 14971 risk management process.
It is not a fixed list of tests. You start from what is already known about your materials, add chemical characterisation, and test only the endpoints that remain open, all documented in a Biological Evaluation Plan and Biological Evaluation Report. EU MDR Annex I (GSPR 10) and the FDA both expect this risk-based approach.
How ISO 10993-1 categorises your device
The nature of body contact and the contact duration decide which biological endpoints you must address.
| Contact category | Contact with | Typical examples |
|---|---|---|
| Surface device | Intact skin, mucosal membranes, breached or compromised surfaces | ECG electrodes, contact lenses, wound dressings |
| Externally communicating | Blood path indirectly, tissue, bone or dentin, circulating blood | IV administration sets, laparoscopes, dialysis catheters |
| Implant device | Tissue or bone, blood | Orthopaedic plates, pacemaker leads, heart valves |
Our biological evaluation process
A risk-based route that avoids unnecessary testing and holds up in review.
- 1
Device & material review
StartWe collect material, supplier, processing and sterilisation information for every patient-contacting part.
- 2
Categorise contact & duration
ISO 10993-1We set the contact category and duration and list the endpoints to address.
- 3
Biological Evaluation Plan
BEPWe review existing data and write a plan that justifies what to test and what not to test.
- 4
Chemical characterisation
ISO 10993-18 · ISO 10993-17We arrange extractables and leachables testing and a toxicological risk assessment.
- 5
Targeted testing
Associated labsWe place and monitor biocompatibility tests in associated labs in India, Poland and the USA.
- 6
Biological Evaluation Report
BERWe bring all evidence together into a BER with a clear conclusion on biological safety.
- 7
Keep it current
LifecycleWe reassess when materials, suppliers, processes, sterilisation or PMS data change.
Biocompatibility endpoints and standards
Common biological evaluation gaps
Our biological evaluation services
Biological evaluation FAQs
What is a biological evaluation of a medical device?
It is a structured assessment, under ISO 10993-1 and within your ISO 14971 risk management process, of whether the materials in a device are safe for the type and duration of body contact. It is documented in a Biological Evaluation Plan (BEP) and a Biological Evaluation Report (BER).
Is biocompatibility testing always required?
No. ISO 10993-1 is risk-based. Existing data, material history, chemical characterisation and toxicological risk assessment can justify not testing some endpoints. Any omitted test must be clearly justified in the BER.
What is included in a Biological Evaluation Report?
Device and material description, contact category and duration, the endpoints considered, chemical characterisation and toxicological risk assessment, test results, justification for any omitted tests, and an overall conclusion on biological safety.
Which ISO 10993 tests does my device need?
It depends on the nature of body contact and the contact duration. Most devices need at least cytotoxicity, sensitisation and irritation; longer contact and implants add systemic toxicity, genotoxicity, implantation and haemocompatibility endpoints.
Does the FDA accept ISO 10993 testing?
Yes. The FDA recognises ISO 10993 standards and applies them through its guidance on the use of ISO 10993-1, which adds some FDA-specific expectations. We plan testing so one programme supports both EU MDR and FDA submissions.
How long does biocompatibility testing take?
A standard panel of cytotoxicity, sensitisation and irritation often takes 6 to 10 weeks. Implantation, chronic toxicity and carcinogenicity studies can take several months, so they should be planned early.
Not sure which ISO 10993 tests you need?
Send us your device and material details using the form below and we'll suggest a test plan at no cost.
