We assist you in Biological safety assessment

Before placing a device on the market, manufacturers must demonstrate its Biological Safety. Many pieces of evidence are typically needed for this, and the principle for collecting and evaluating such evidence is outlined in two standards – ISO 14971:2019 and ISO 10993-1:2018.

 

A risk-based assessment of Biological Safety takes multiple factors into account. These include, but are not limited to:

  • suitability of raw materials used to manufacture and package the device,
  • the interaction of the device and its packaging,
  • the manufacturing process and the adjuvants/contaminants that it introduces in the device,
  • leachable substances,
  • the suitability of the cleaning and sterilization procedures,
  • the possible degradation of the device during its shelf life and clinical use (whole life cycle of the device), and
  • experience gathered from clinical use of the device.

 

A strong emphasis is placed on collecting, documenting, and discussing all relevant evidence related to the above-mentioned points for demonstrating biological safety.

 

Furthermore, ISO 10993-1:2018 categorizes the devices based on the nature and duration of contact that these will have with the patient and prescribes a list of biological endpoint tests that should be considered for devices in each category.

 

It is required to present due justification of testing (endpoint and methodology) that is adopted to demonstrate Biological Safety of the device

 

It is required to present due justification of testing (endpoint and methodology) that is adopted to demonstrate Biological Safety of the device, as well as a justification of testing deemed not relevant, necessary, or appropriate for the evaluated device.

 

It has become imperative for assessments of Biological Safety to present rationale for worst case devices (if applicable) and to consider the impact of ageing/degradation of the device during its shelf life and clinical use.

 

On an industry-wide level, the implementation of the MDR has also invited greater scrutiny of Biological Safety Assessments during audits by Notified Bodies.

 

 

POINTS OF INCREASED FOCUS AFTER UPDATE OF ISO 10993-1 IN 2018

 

  • A risk-based assessment of Biological Safety takes multiple factors into account; all factors should be presented in context and discussed
  • Ageing and degradation of the device during storage and clinical use should be considered
  • Testing strategy should be carefully constructed. In view of reducing animal life cost, testing can be waivered. However, when endpoints are waivered, these should be adequately justified
  • Testing methodologies and conditions are more under scrutiny (i.e. the extraction conditions used for preparing the test extracts need to be adequately justified)

 

To prepare a comprehensive standard-compliant evaluation/assessment of the Biological Safety of medical devices, Medidee has a committed team of experts. We have a long track record of supporting our clients in defining the most adequate testing strategy, and for preparing rationales to waiver the end-point tests that are unnecessary.

 

 

We welcome clients at all stages of development: from the early design concept stage to post-market authorization. Our approach will be unique and specifically tailored for your product.

 

 

webinar biocompatibility

Biocompatibility of medical devices is a critical and evolving subject. As long as a device has any direct or indirect tissue contact, FDA and other authorities will need biocompatibility information in the submission. During this on-demand webinar, you will be guided through the Biocompatibility Workflow by our expert Dr. Adrien Marchand.

EXPERTISE FOR BIOLOGICAL SAFETY ASSESSMENT AVAILABLE AT MEDIDEE:

  • Review of all pertinent documentation – collection and compilation
  • Preparation of an initial Biological Risk Assessment
  • Preparation of test plans for the chemical/physical characterization and biological endpoints
  • Support on communication with test labs
  • Evaluation of the test results, including calculation of Allowable Limits (for identified residues) as part of the Toxicological Risk Assessment (TRA)
  • Updates of previous Biological Risk Assessments

Contact Medidee to discuss your needs