Biocompatibility

What Is a Biological Evaluation Report (BER)?

A Biological Evaluation Report (BER)is the documented conclusion of a medical device’s biological safety assessment under ISO 10993-1:2025. It compiles material characterization, risk analysis, existing data, and any biocompatibility testing into a single, submission-ready record demonstrating that a device is biologically safe for its intended use.

The BER is the endpoint of a lifecycle that begins with a Biological Evaluation Plan (BEP). The BEP defines the evaluation strategy and endpoints up front; characterization, literature review, and testing follow only where data gaps remain; and the BER presents the final, reasoned safety conclusions to regulators. Groenakker manages this entire lifecycle — from BEP through BER — in line with the FDA’s current biocompatibility guidance and EU MDR expectations.

Biological Evaluation Simplified

Phase IProject Scoping

01 - Initial Meeting — Understand Device(s) and agree to scope of project.

02 - Client issues purchase order to Groenakker for project scope.

Phase IIEvaluation Details

03 - Client provides necessary information by filling out Groenakker Biocompatibility Request Form.

Phase IIIEvaluation Drafting and Revision

Estimated TAT: 2 Weeks for Initial Draft

04ᵃ - Groenakker will draft a comprehensive initial BEP to minimize regulatory risk.

04ᵇ - We provide up to 3 revisions of the BEP to meet the risk tolerance of each individual client.

Phase IVFinal Approval

Estimated TAT: 1 Week

05 - Final approved BEP delivered to client. Ready to execute testing (as necessary).

Comprehensive Evaluation

With a constantly changing compendium of standards and guidance documents, it can be daunting to know where to start and how to adequately document the biocompatibility of your device. With risk analyses providing a firm foundation, we clearly document each step of the biocompatibility assessment process to provide clarity to decisions made and ensure our clients put their best foot forward in regulatory reviews.

STEP 1: DEVICE CONTACT TYPE(S) & DURATION(S) CHARACTERIZATION

A critical key to success in any biological evaluation is understanding the nature of the device's intended use and proper contact type & duration characterization. This includes evaluation of how a device may contact patients as well as the surgical staff operating it.

Biological Evaluation FAQ

What is a Biological Evaluation Report (BER)?

A Biological Evaluation Report (BER) is the documented conclusion of a medical device's biological safety assessment under ISO 10993-1. It compiles material characterization, risk analysis, existing data, and any biocompatibility testing into a single, submission-ready record demonstrating that the device is biologically safe for its intended use.

What is the difference between a BEP and a BER?

The Biological Evaluation Plan (BEP) is created at the start of a project to define the evaluation strategy, endpoints, and any testing required. The Biological Evaluation Report (BER) is the final deliverable that documents the results and safety conclusions of that evaluation. Together they bookend the ISO 10993-1 biological evaluation process.

Is biocompatibility testing always required?

No. ISO 10993-1 emphasizes evaluation over testing. A thorough gap assessment often shows that existing data, material characterization, and literature are sufficient to establish biological safety, so testing is only planned where genuine data gaps remain — minimizing cost and turnaround time.

Which standard governs the biological evaluation of medical devices?

ISO 10993-1:2025 is the overarching standard, supported by the wider ISO 10993 series (for example -17 for toxicological risk assessment and -18 for chemical characterization). Groenakker also follows the FDA's current biocompatibility guidance and EU MDR expectations.

How long does a biological evaluation take?

Groenakker delivers an initial BEP draft in about two weeks, with final approval roughly one week later. Overall BER timing depends on whether device testing is required following the gap assessment.

Groenakker works closely with our clients to create bespoke biological safety evaluations.
Whatever biocompatibility needs you have, we have the solution and expertise to drive success.

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