Biological Evaluation of Medical Devices

Biological Evaluation is performed to measure the potential risk arising from the use of medical devices in Humans. It is a step by step process where possible biological risk from material or device is evaluated and demonstrated that the device is safe to use in humans. Biological Evaluation is a risk management activity as part of ISO 14971.

A systematic Biological Evaluation has following steps

· Biological Evaluation Plan (BEP)

· Performance of Tests

· Biological Evaluation Report (BER)

Biological Evaluation Plan

A Biological Evaluation Plan is a thorough review of device information, checking the compliance to the corresponding standards, analyzing and evaluating the biological risk associated with the device, identifying gaps and proposing the tests if required to demonstrate the safety of the device.

The Biological Evaluation Plan should be written by a knowledgeable and experienced individual/team. A well-drawn biological evaluation plan will help to wave off many testing requirements with proper justification. Avoiding unnecessary testing of the device save cost and time to the organization

The Biological evaluation starts with the characterization of Medical Devices. This involves

Categorization of Medical device for Biological Evaluation

A. Nature of body contact:

· Surface contacting device

· Externally communicating device

· Implant device

· Non contacting device

B. Duration of contact

· Limited exposure

· Prolonged exposure

· Long-term exposure

· Gathering and reviewing information on configuration/design of Medical device

· Material characterization

· Chemical characterization

· Extractable

· Leachable

· Degradation products

· Evaluation of Toxicological Data Packaging and Sterilization

Recommendations: Identification and recommendation of tests based on the end points to be considered as per Annex A of ISO 10993-I according to their nature of body contact, duration of contact. and gaps if observed in material and chemical characterization.

Biological Evaluation Report

The Biological Evaluation Report is a document which summarizes all the reviews performed, chemical and biological tests conducted, toxicological risks assessments and justifications provided not performing the tests, wherever the tests are waved off, collective summary of all biological tests performed and justifications for tests not performed.

The Report include all points discussed in the biological evaluation plan including

· Summaries of literature survey,

· Gap analysis, device configuration,

· Material characterization,

· Chemical characterization,

· Biocompatibility tests,

· Toxicological risk assessments,

Reviews and analysis to demonstrate that the medical device will not cause any potential risks to patients and intended users during the course of its use.

Contact us for:

Biological Evaluation Plan/Report

Written by:

Experienced and Knowledgeable Team

Email:info@ikenreg.com