Biological Evaluation of Medical Devices
Biological Evaluation of Medical Devices
Biological response to a medical device is wide and complex. The choice of safer constituent material may result in less functional device. Hence Biological Evaluation plays important role where the constituent material of device interacts with tissue.
The primary aim of EN ISO 10993-1: “Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process”, is to protect the humans from potential biological risks arising from the use of medical devices. However, Medical Device Directive (MDD) and the Medical Device Regulation also provides Essential requirements and General Safety and Performance requirements of Medical device.
It is intended to describe the biological evaluation of medical devices within a risk management process in accordance with ISO 14971:2007, as part of the overall evaluation and development of each medical device. This risk management process involves identification of biological hazards, estimation of the associated biological risks, and determination of their acceptability. This approach combines the review and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests, thus enabling a full evaluation to be made of the biological responses to each medical device, relevant to its safety in use.
The primary role of this document is to serve as a framework in which to plan a biological evaluation. A secondary role is to utilize scientific advances in our understanding of basic mechanisms, to minimize the number and exposure of test animals by giving preference to in vitro models and to chemical, physical, morphological, and topographical characterization testing, in situations where these methods yield equally relevant information to that obtained from in vivo models.
Biological Evaluation Plan
A Biological Evaluation Plan will be drawn which can be used to prove the safety of the device by demonstrating compliance to corresponding standards and avoiding unnecessary testing of the device
- The biological evaluation plan will the part of the Risk Management Plan
- The biological evaluation plan will be drawn up which will include:
- Applicable information from the published literature
- Review and approval of the plan as part of the overall design control process
- Review of the final conclusions of the evaluation and the approval of any additional testing required
- Final review and approval of the outcomes of the biological risk assessment
- Factors to be considered while drawing Biological Evaluation Plan
- The material(s) of construction (ie. direct and indirect tissue contacting materials)
- Medical device configuration (e.g., size, geometry, surface properties)
- Intended additives, process contaminants and residues during the manufacturing of the device
- The manufacturing processes
- Packaging materials that directly or indirectly contact the medical device
- Leachable substances (see ISO 10993-17 and ISO 10993-18)
- Other components and their interaction in the final product
- The performance and characteristics of the final product
- The physical and chemical characteristics of the device
- Systemic effects and local effects of implantable devices
- Existing toxicology and other biological safety data
- Identify and characterize biological and toxicological hazards associated with the medical device product in an effort to characterize risk
- Utilize the step-wise approach to save time and money
Interpretation of biological evaluation data and overall biological risk assessment
Expert assessors who have the necessary knowledge and experience shall determine and document:
- The strategy and planned content for the biological evaluation of the medical device
- The criteria for determining the acceptability of the material for the intended purpose, in line with the risk management plan
- The adequacy of the material characterization
- The rationale for selection and/or waiving of tests
- The interpretation of existing data and results of testing
- The need for any additional data to complete the biological evaluation
- Overall biological safety conclusions for the medical device
Biological Evaluation Report
- At the end The Biological Evaluation Report will be generated
- The Biological Evaluation Report will be a collective summary of all biological tests performed and justifications for tests that are not performed
- The report will include supporting data from the literature, assessment of data, gap analysis for already available information for biological safety, rationale for why additional information is required or not required
- A statement confirming the biological risk analysis and risk controls that have been completed
The report is used to demonstrate that a medical device will not cause any potential risks to patients and intended users during the course of its use
