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.
This page explains Patient Guard’s Biological Evaluation services, supporting manufacturers with Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs) and ISO 10993 compliance. If you're looking for a broader understanding of biological evaluation, including biological risk assessment, chemical characterisation, biocompatibility, toxicological evaluation, biological endpoints and risk-based testing under ISO 10993, read our Complete Guide to Biological Evaluation of Medical Devices.
Since 2017, we have supported medical device manufacturers with technical documentation and regulatory compliance for over 9 years.
We support ambitious start-ups, scaling SMEs, and global manufacturers with comprehensive medical device compliance and market access.
Our team understands biological evaluation requirements and how they fit into EU MDR, UK MDR, and global regulatory submissions.
We help you avoid unnecessary, expensive testing by utilising a highly structured, evidence-based biological evaluation strategy.
We prepare or review complete Biological Evaluation Plans that clearly define the strategy, scope, and target endpoints for your device.
We draft or review Biological Evaluation Reports that thoroughly document the final safety assessments and justify your conclusions.
We assess your existing biological safety documentation directly against ISO 10993-1 requirements to identify non-compliance.
We isolate relevant biological endpoints based precisely on your device type, the nature of body contact, and the total contact duration.
Our experts review available raw material, manufacturing data, and chemical characterisation profiles to safely support safety conclusions.
We clarify whether additional lab testing is needed and provide defensible scientific justification where testing is unnecessary.
Short-term contact devices (less than 24 hours) often require a focused biological evaluation strategy based on device materials, manufacturing processes, and intended patient contact.
Examples include:
Patient Guard helps manufacturers determine the appropriate biological endpoints, assess available evidence, and identify whether additional testing is required under ISO 10993-1.
Devices with prolonged or permanent patient contact require more extensive biological safety assessments.
These devices may require consideration of:
Our consultants develop risk-based biological evaluation strategies that support both regulatory compliance and patient safety.
While standalone software generally does not require biological evaluation, software systems integrated with patient-contacting hardware often form part of the overall biological safety assessment strategy.
We help manufacturers ensure biological evaluation activities align with broader technical documentation and risk management requirements.
Combination products and drug-delivery devices present unique biological safety challenges.
Patient Guard supports manufacturers of:
Our team evaluates biological risks associated with materials, drug interactions, extractables, leachables, and patient exposure pathways.
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.
Challenge
A manufacturer required a Biological Evaluation Plan and Biological Evaluation Report to support MDR compliance for a patient-contacting administration set.
Solution
Patient Guard reviewed device materials, manufacturing processes, available supplier information, and existing biological data before preparing a complete BEP and BER aligned with ISO 10993-1.
Outcome
The manufacturer obtained a robust biological evaluation package suitable for inclusion within the Technical Documentation.
Challenge
A manufacturer needed to determine whether additional biocompatibility testing was required for an infusion device following design modifications.
Solution
We performed a biological risk assessment, reviewed material changes, evaluated existing evidence, and justified the biological evaluation strategy using a risk-based approach.
Outcome
The manufacturer avoided unnecessary testing while maintaining compliance with regulatory expectations.
Challenge
A manufacturer required support addressing biological safety questions raised during conformity assessment.
Solution
Patient Guard conducted a gap analysis of the biological evaluation documentation and developed additional scientific justification addressing identified deficiencies.
Outcome
The manufacturer strengthened the biological evidence package and improved readiness for regulatory review.
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:
A complete guide to NHS DTAC compliance for digital health manufacturers, covering the five DTAC assessment areas, required evidence, clinical safety, data protection, technical security, interoperability and usability, and how to prepare your digital health technology for NHS procurement.
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Post-Market Performance Follow-up (PMPF) is a fundamental requirement under the EU In Vitro Diagnostic Regulation (IVDR), ensuring that manufacturers continually monitor the scientific validity, analytical performance and clinical performance of their in vitro diagnostic medical devices after CE marking. This guide explains IVDR PMPF requirements, PMPF Plans, PMPF Reports, Annex XIII expectations and how ongoing performance monitoring supports continued regulatory compliance throughout the device lifecycle.
Scientific Validity is the first pillar of IVDR Performance Evaluation and provides the scientific foundation demonstrating that an analyte or biomarker is associated with a specific clinical condition or physiological state. This guide explains Scientific Validity under Regulation (EU) 2017/746, including literature reviews, Scientific Validity Reports, Annex XIII requirements, evidence appraisal and how Scientific Validity supports successful CE marking.
Performance Evaluation is one of the most important requirements under the EU In Vitro Diagnostic Regulation (IVDR). Every manufacturer must demonstrate that their in vitro diagnostic medical device achieves its intended purpose through robust scientific validity, analytical performance and clinical performance evidence. This guide explains every stage of IVDR Performance Evaluation, including Performance Evaluation Plans (PEPs), Performance Evaluation Reports (PERs), Post-Market Performance Follow-up (PMPF) and how Performance Evaluation supports successful CE marking under Regulation (EU) 2017/746.
Understanding how your in vitro diagnostic device is classified under the EU IVDR is one of the first and most important steps towards regulatory compliance. This guide explains the IVDR classification rules, the differences between Class A, B, C and D IVDs, how Annex VIII is applied, and how classification affects conformity assessment, technical documentation and Notified Body involvement.
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.
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