Biological Evaluation Plan for Medical Devices

WHAT IS A BIOLOGICAL EVALUATION PLAN (BEP)?

A biological evaluation plan (BEP) is an essential step in the medical device production process. This plan is aligned with ISO 10993, the international series of standards for the biological evaluation of medical devices. The 10993 series outlines a systematic approach for evaluating the potential hazards and harms between a medical device and the human body. 

This vital document specifies the device’s materials, its intended use, and patient contact duration. It identifies the required tests to assess the device's safety based on these details.

WHAT IS THE PURPOSE OF A BIOLOGICAL EVALUATION PLAN?

The primary goal of a biological evaluation plan is to ensure the safety and biocompatibility of the medical device, reducing patient harms. It assesses the potential hazards that could arise from the contact between the device and the patient’s body. This includes any biological hazards that could cause harm to the patient, either directly through damage to cells or tissues, or indirectly through the release of harmful substances.

Moreover, biological evaluation aids in demonstrating compliance with regulatory guidelines such as ISO 10993. This helps in gaining approval from regulatory bodies, thereby enabling the device to reach the market and contribute to patient care.

WHAT IS THE BIOLOGICAL EVALUATION PLAN PROCEDURE?

The biological evaluation process is a cohesive effort that begins with gaining insight into the medical device, its intended usage, and associated risks. Following the creation of an ISO 10993-compliant BEP, biocompatibility testing is performed, and results are interpreted alongside detailed risk assessments.

1. Develop a biological evaluation plan (BEP): Create a BEP based on ISO 10993 guidelines. The BEP should outline the necessary tests to evaluate the device's safety and biocompatibility.
2. Testing and risk assessments: Carry out biocompatibility testing as per the BEP and ISO 10993 biocompatibility guidelines. By incorporating a diverse range of tests in specialised labs, it thoroughly examines the potential effects on a patient's biological system.
3. Biological evaluation report (BER): The data gathered from the testing stage is interpreted and captured in a biological evaluation report for comprehensive documentation. As per ISO 14971, a conclusion on the benefit/risk ratio for biological hazards is drawn. A risk assessment is performed, and a determination is made regarding the device's biocompatibility. 

It's important to remember that biological evaluation is a continuous process, requiring ongoing post-market monitoring and updates to align with evolving standards.

WHAT ARE THE FACTORS CONSIDERED DURING BIOLOGICAL EVALUATION?

• Responsibilities: This outlines the responsibilities, technical skills, and expertise of all individuals involved in the evaluation process.
• Material selection: In this stage, the device's potential materials are evaluated based on their properties and clinical experiences, resulting in the selection of the most suitable ones.
• Material characterisation: This stage presents the device's manufacturing process, materials, and potential residues in line with ISO 10993 standards. It includes identifying and quantifying materials and leachable substances and assessing degradable materials' characteristics.
• Literature review: A literature review is performed according to ISO 10993-1 and ISO 14971, examining existing toxicological data and potential biological risks related to the materials.
• Testing selection: The last step, adhering to ISO 10993-1 and ISO 14971, involves selecting pertinent tests, especially when the risk level does not align with the device's intended use.

WHY CHOOSE TÜV SÜD

Expertise: TUV SUD has a team of biocompatibility experts with extensive knowledge and experience in developing biological evaluation plans for medical devices. Our team members have relevant degrees, certifications, and hands-on experience in the field, enabling them to provide accurate and reliable assessments of the Biological Evaluations Plans to our clients.

Regulatory Compliance: TUV SUD is familiar with major global medical device regulations and standards and ensures that all biological evaluation plans are compliant with the latest requirements.

Timeliness: We understand that time-to-market is critical for our clients, and we work diligently to ensure that all deliverables, including biological evaluation assessments, are completed within the required timeframe. Our project management team ensures that all deadlines are met and that our clients receive high-quality deliverables on time.

OUR TESTING SERVICES AT A GLANCE

TÜV SÜD provides a suite of testing and certification services to ensure medical device safety and compliance. 

These include biocompatibility testing, which evaluates a device's compatibility with living tissue, and MRI safety testing to minimise risks in magnetic resonance imaging environments. 

Additionally, packaging evaluations are conducted to maintain device integrity, while reusable device testing ensures safety and functionality through multiple uses. Sterilisation validation guarantees effective sterilisation processes, and compliance with IEC 60601 focuses on medical electrical equipment safety and performance standards.

Speak to our team today