Our Biological Evaluation Plan and Report services support medical device manufacturers in demonstrating biological safety in line with ISO 10993 and regulatory expectations. Patient Guard helps you prepare, review, and strengthen your biological evaluation documentation for CE marking, UKCA marking, and global regulatory submissions.
Medical device manufacturers must demonstrate that their devices are biologically safe for their intended use, patient contact type, and duration of contact.
A Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) are key documents used to justify biological safety and determine whether additional biocompatibility testing is required.
Patient Guard provides expert Biological Evaluation Plan and Report services for medical device manufacturers, supporting compliance with ISO 10993-1 and applicable regulatory requirements.
We help manufacturers assess material characterisation, device contact, existing evidence, toxicological risks, and biological endpoints to determine a compliant biological evaluation strategy.
Whether you are preparing a new biological evaluation, updating legacy documentation, or responding to Notified Body feedback, we provide a structured and compliant approach.
Biological evaluation is required to demonstrate that a medical device is safe for its intended use and does not present unacceptable biological risks.
A compliant biological evaluation typically considers:
The biological evaluation should be risk-based, scientifically justified, and maintained throughout the device lifecycle.
We assess your device, intended use, patient contact type, and current documentation status.
We review existing material data, test reports, risk management files, and technical documentation.
We define the biological evaluation strategy and applicable biological endpoints.
We prepare or update the report, documenting evidence, testing, gaps, and conclusions.
We support final checks, updates, and responses to auditor or Notified Body feedback.
We support biological evaluation documentation for a wide range of medical devices, including:
From
Ensure regulatory compliance and market readiness with expertly prepared Biological Evaluation Plans and Reports. Pricing starts from £6,000, with preferential rates for multiple products.
Review of device materials, intended use, and existing data against ISO 10993 requirements.
Preparation of Biological Evaluation Plan and Report, including endpoint assessment and justification strategy.
Final documentation checks and support for Notified Body review or Technical File integration.
A Biological Evaluation Plan defines the strategy for assessing the biological safety of a medical device, including applicable biological endpoints and required evidence.
A Biological Evaluation Report documents the results of the biological evaluation and provides the justification that the device is biologically safe for its intended use.
Biological evaluation is generally required for medical devices with direct or indirect patient contact. The depth of evaluation depends on the device type, materials, contact duration, and intended use.
Not always. Testing may not be required where sufficient existing evidence, material data, chemical characterisation, and scientific justification are available.
Yes, we can review, update, and remediate existing biological evaluation documentation to align with ISO 10993 and regulatory expectations.
Click on the links below to discover more:
EUDAMED enters a new phase as four modules become mandatory from 28 May 2026. Learn what changes and how to prepare for compliance.
Medical devices exist to improve health outcomes, but every device carries potential risk. Managing those risks in a structured, documented, and defensible way is essential for regulatory approval and patient safety.
Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.
Medical device labelling is more than a packaging exercise. It is a regulatory requirement that communicates essential information about a device’s identity, safety, and intended use.
Regulatory approval is not the end of scrutiny, it is the beginning of structured data collection.
If you are implementing a medical device QMS, preparing for certification, or recovering from audit findings, understanding ISO 13485:2016 requirements is non-negotiable.
Speak to one of our regulatory and compliance experts to arrange an obligation-free call. Our experienced team is ready to help you get your medical device to market.
UK Office
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office
Thank you! The checklist is now ready to download.
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office
