Medical Device Biological Evaluation Plan

What is Biological Evaluation Plan?

Medical devices that have direct or indirect contact with patients or users must be assessed for biocompatibility to ensure they are safe for their intended use.

A Biological Evaluation Plan (BEP) is a structured, risk‑based assessment that evaluates the potential biological risks of a medical device based on its nature of contact (e.g. skin, mucosal, blood) and contact duration. These factors determine the relevant biological endpoints that must be addressed using existing data and/or testing.

In line with ISO 10993‑1, the BEP reviews all available information – such as material data, manufacturing processes, and previous test results – to identify gaps in biological evidence. These gaps are then used to define a clear testing strategy to fully assess biological safety and support regulatory compliance.

ISO 10993‑1 requires that “the biological evaluation shall be planned, carried out and documented by knowledgeable and experienced professionals”.

Using our in-house biocompatibility specialists, we develop regulator-ready BEPs that:

Define the biological testing required for your device.

Identify and leverage existing data to reduce unnecessary testing.

Provide a clear rationale aligned with risk management principles.

Once we receive your approval to proceed, we systematically collect and assess device-specific information to support the development of a risk-based Biological Evaluation Plan (BEP), in line with ISO 10993-1.

This assessment considers the entire life cycle of the medical device, including manufacture, processing, packaging, storage, clinical use (including repeat or long-term use where applicable), reprocessing (if relevant), and end-of-life.

This assessment includes the following key elements:

Intended Use, Clinical Indication, and Patient Population

A definition of the device’s intended purpose, variants, clinical application, target patient population, and conditions of use. This information supports determination of contact type, contact duration, and foreseeable misuse across the device life cycle.

Device Configuration and Physical Characteristics

A detailed description of the device design, configuration(s), geometry, dimensions, surface characteristics, and any features that may influence biological interaction during handling, use, and clinical exposure.

Material Composition

Identification and characterisation of all patient-contacting materials, including base materials, coatings, inks, adhesives, and ancillary components, with consideration of material changes over time or through processing, storage, or clinical use.

Manufacturing Processes

Review of the complete manufacturing workflow, from raw materials through processing, assembly, and finishing, to identify potential sources of biological risk introduced during the manufacturing processes.

Manufacturing Additives and Processing Agents

Assessment of substances used during manufacturing (e.g. lubricants, mould-release agents, solvents, cleaning agents) that may leave residues or influence the biological safety of the finished device.

Sterilisation and Reprocessing (Where Applicable)

Evaluation of sterilisation method(s) (e.g. steam, ethylene oxide, irradiation) and, where relevant, reprocessing or re-sterilisation cycles, including consideration of residuals, material changes, and cumulative impact over the device lifetime.

Packaging, Transport, and Storage

Assessment of packaging materials and configurations, including their potential to introduce contaminants or interact with the device during transport, storage, and shelf life.

Leachables, Extractables, and Degradation Products

Identification of substances that may be released from the device during storage, clinical use, or repeated exposure, as well as degradation products arising from ageing, sterilisation, or environmental conditions over the intended lifetime.

Available Toxicological and Biological Safety Data

Compilation and review of existing biological and toxicological information, including literature data, supplier documentation, prior testing, and previous evaluations, to support a scientifically justified biological safety assessment.

Local and Systemic Effects (Including Implantable Devices)

Evaluation of potential local tissue responses and systemic effects, taking into account duration and frequency of exposure, cumulative effects, and the intended clinical environment.

Clinical Experience and Post-Market Information

Review of relevant clinical data, including information from similar or predicate devices, post-market surveillance, and reported adverse events, to support the biological risk assessment across the device life cycle.

Following completion of the activities outlined in the Biological Evaluation Plan, a final assessment of the data is given within The Biological Evaluation Report.