The biological safety of medical devices includes aspects of biocompatibility or toxicity of materials used, cleaning and production residues or contamination, as well as possible hazards from infectious microorganisms. In the case of insufficient biocompatibility, inadequate biological safety can lead to undesirable physical (tissue) reactions and toxic effects and also have a negative impact on the health of the patient as well as the safety and functionality of the medical device. Lack of product purity and, where applicable, sterility or incorrect reprocessing of reusable medical devices can lead to hazards to patients, users and third parties from infectious microorganisms. In order to prevent these undesirable events, you as a medical device manufacturer are therefore obliged to ensure the biological safety of your medical device in accordance with the requirements of EN ISO 10993-1 and any additional applicable standards. For medical devices placed on the market under sterile conditions, there are additional requirements to ensure sterility, depending on the sterilization process selected.
The biological safety of medical devices is not only limited to EN ISO 10993-1, but also there are additional interfaces with risk management according to ISO 14971. Our Metecon team of experts is very familiar with both topics and will support you in identifying relevant risks and in planning, implementing and documenting the appropriate test strategy.
Planning and execution of biocompatibility assessments according to EN ISO 10993-1
Planning a successful biocomp assessment strategy starts with the selection of suitable biocompatible materials for the actual product and for the primary packaging, as well as the identification of all planned processing steps and their potential influence on the biocompatibility of the final product. The medical device is then categorized according to the type and duration of body contact. This categorization results in the relevant endpoints to be considered as part of the testing strategy. Please note that in addition to the requirements of EN ISO 10993-1, there may be additional relevant aspects arising from risk-management, product-specific standards or from the requirements of non-European target markets, such as. e.g., FDA guidance on the application and interpretation of EN ISO 10993-1 (Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"). All biological safety planning processes are documented in the Biological Evaluation Plan.
Performance of the biocompatibility testsBiocompatibility testing is performed exclusively in accredited testing laboratories. Here, the first step is the chemical characterization of the materials used and all auxiliary and operating materials involved. Based on the results of the chemical characterization and, if necessary, the toxicological evaluation of the identified substances, the need for further biological testing is identified.
Documentation of results and final Biological Safety Assessment
The results of the biological safety testing, toxicological evaluations, and data from a possible literature search are documented and finally evaluated in the biological assessment report.In the development of new medical devices, the biocompatibility of the final product should be considered during planning and development by selecting appropriate materials and/or screening tests during development. However, already approved medical devices and legacy devices must also be subjected to a renewed revision of the biological safety assessment if there are changes in the production process or the materials used.
That's all? Well, not yet!
The Biological Safety Assessment process accompanies the entire product life cycle and remains relevant even after your product has been launched.
Unsere Leistungen im Bereich biologische Sicherheit
- Consulting test strategy according to EN ISO 10993-1 for CE-approvals/FDA-approvals
- GAP analyses on existing regulations and standards (e.g. MDD/MDR or EN ISO 10993-1)
- Communication with testing laboratory (obtaining quotations, supervision of studies in the laboratory)
- Preparation of planning documents and reports on biological safety
- Identification of "worst case" products
- Toxicological evaluation (collaboration with expert toxicologists).
- Preparation of planning documents and reports for reprocessing of reusable medical devices for CE approvals/FDA approvals.
- Preparation of planning documents and reports for sterilization of sterile delivered medical devices for CE and FDA approvals.
- Planning of test strategies for reprocessing
- Identification of "worst case" products
- Influence of reprocessing on biocompatibility of medical devices.
Also in brief
- Audit preparation for biosafety customers.
- Supporting the customer in supplier audits, e.g. in the testing laboratory
- Prepare material safety data sheets from test reports and toxicological databases.
We look forward to meet you!
Metecon has a team of Excellent employees who together have extensive experience in all the areas mentioned. Feel free to contact us. We look forward to getting to know you.