Biological Evaluation Plan (BEP)

Regulators now require a BEP as the foundation of any biocompatibility assessment under ISO 10993-1 and MDR. To be accepted, it must be authored and signed by a qualified or certified biocompatibility specialist with relevant regulatory and toxicological expertise. A Biological Evaluation Plan defines the scientific rationale for demonstrating device safety and ensures that only scientifically justified tests are performed.

Typically 5–15 working days, depending on device complexity and technical data availability. Complex or combination products may require slightly longer.

Yes, provided materials, processes, and sterilization methods are equivalent. Our experts perform detailed equivalence and gap analyses to justify the reuse of existing data, saving time and cost.

We typically require the device Bill of Materials (BOM), manufacturing and sterilisation process descriptions including additives, mould release and cleaning agents, material and supplier information, product drawings or photos, and a copy of the IFU (Instructions for Use). Any existing test reports or toxicological data are also highly valuable for reducing unnecessary testing and overall risk for the device.

The IFU supports definition of the intended clinical use, contact duration with healthcare professional and patient, highlights underlying, sometimes critical factors (temperature, additional sterilization- all contribute to thorough tailored determination biological endpoints under ISO 10993-1. Without it, biological risks may be misclassified, leading to incomplete or excessive testing.

Typically BEP is required for the Final Medical Device.

However, if the prototype will be used for design validation, clinical investigation, or pre-market submission, then Biological Evaluation is advised.

We can support your proof-of-concept or non-clinical prototype projects by consulting with simplified biological assessment and literature searches. Our specialists can advise on the most appropriate and efficient approach for your development stage.

Packaging materials can significantly affect extractables and leachables outcomes. Ideally, packaging details should be available before finalising the BEP to ensure a complete risk evaluation. However, if packaging is still under development, we can provisionally define the plan and update it once final materials are confirmed.

Absolutely. We provide independent, science-based recommendations on appropriate in-vitro, analytical, or animal testing methods depending on device type, contact category, and material chemistry. Our goal is to optimise your testing strategy to meet ISO 10993 and regulatory expectations with minimal redundancy.

A standard BEP typically requires 5–10 working days once all required information is received. More complex combination products or implantable devices may require longer, particularly if detailed material or chemical characterization data must be reviewed.

• BEP (Biological Evaluation Plan): Defines the overall strategy and rationale before testing.
• TRA (Toxicological Risk Assessment): Evaluates patient exposure to chemical substances and their toxicological significance (ISO 10993-17).
• BER (Biological Evaluation Report): Summarises all biological data, test results, and risk assessments after testing to conclude on biocompatibility.

A formal BEP may not be required for non-patient-contacting devices (e.g., external hardware or software components). However, regulators still expect a documented justification or biological risk statement within the technical file explaining why a full biological evaluation is not applicable.