How your materials are checked for biological safety
What the Biological Evaluation Plan is, what you provide for it, and what happens when a material's contact details are missing.
Where to find it
My Cases → Your case → Device information → Needs your answer
You need
- An MDR case — an IVDR case's tracker does not carry this row.
- A list of the materials your device is made of, and how each one touches the body.
If any part of your device touches a patient, the technical file has to show that those materials are safe to touch. The standard for that is ISO 10993-1, and the first thing it asks for is a plan: which biological questions the testing will have to answer, and why those and not others. That plan is one of the rows on your technical-file tracker.
| Document | What it is |
|---|---|
| Biological Evaluation Plan | How the device's materials are shown to be safe for the body. |
It is a plan, not a set of results. It says what has to be looked at; the testing itself, and its outcome, are recorded in the Verification and Validation Report.
What you provide
Complya prepares material information from your documents. When your declaration or clarification is needed, your expert releases a focused request under "Needs your answer" in Device information. Read the prepared information and complete that request; your expert reviews it before finalising the factual basis.
| What we ask | What it means |
|---|---|
| Material | The name you use for it — for example "Medical-grade silicone". |
| Grade or standard | Optional. The grade or standard it is made to, if it has one — for example "USP Class VI". |
| Contact type | Choose Direct for contact with the patient, Indirect for contact through fluids or gases, or None for no body contact. |
| Contact site | Where on or in the body it touches. Relevant when the material has body contact. |
| Contact duration | For how long it touches. Relevant when the material has body contact. |
Contact site and duration remain visible for every row. For a material with body contact, choose the matching site and duration from the fixed lists. The sites run from intact skin, mucosal membrane and a broken skin surface, through blood paths and tissue or bone, to an implant in tissue, bone or blood. The duration choices are Limited (up to 24 hours), Prolonged (more than 24 hours and up to 30 days), and Long term (more than 30 days).
What happens when a contact profile is incomplete
Contact site and duration are needed to work out the biological questions for a material that touches the body. If the sources cannot settle these details, your expert can release a clarification request. Supply the missing information through that request.
If a case does reach your expert with a material still incomplete, the plan says so rather than guessing: the materials are listed, the section on body contact says how many profiles are incomplete, and the per-material list marks each incomplete one as "to be completed before endpoints can be identified".
Reading the plan
The plan lists your materials, states how many of them contact the body, and then, for each one that does, names the biological endpoints to be evaluated — the kinds of question the testing has to answer, such as cytotoxicity, sensitization or irritation. It also names the documents it is read with, including your risk management file.
Like every document in the file, you read it in your case only after the whole technical file has been delivered.
What happens next
- Your expert reviews the plan, answers the parts that are theirs and issues it; the tracker row then reads "Issued — awaiting full-file release".
- This row counts toward release: your technical file cannot be released while the plan is not issued.
- If your material list changes later, the issued plan has to be reviewed and re-issued before the file can be released — that is normal revision work, not a fault.
Related guidance
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.
European Commission — Medical Devices: New regulationsRegulation (EU) 2017/745 — Medical Device RegulationRegulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices