Biological evaluation and chemical characterisation

In the EU MDR regulation, the Biological Evaluation report is a key document in the Technical File. For manufacturers it is mandatory to document biocompatibility and toxicological safety of the medical device. according to the ISO 10993 standards. 

We are very experienced in assessment of biological and toxicological safety and can help you choose the right tests and chemical analyses.

Brian S Nielsen

Tel.: +45 4516 9140
bsn@remove-this.dhigroup.remove-this.com

Safety assessment and ISO 10993-1 requirements

The updated version of ISO 10993-1 published in 2018 sets new and increased requirements of how to evaluate and document the biocompatibility and toxicological safety of medical devices. This includes new criteria for device categorisation, requirements for physical and chemical information and characterisation, and information on additional biological endpoints for evaluation of the biological safety.

The US FDA has included ISO 10993-1 in the list of recognised standards. Over time, the standard is expected to be accepted as a harmonised standard in the EU setting the requirements for MDR compliance. 

The process of updating the ISO 10993 series is ongoing. We are actively involved in this and therefore fully updated on best practices. 

Our solutions for safety and compliance

  • Biological Evaluation Report according to ISO 10993-1 and US FDA guidelines
  • Biological Evaluation Plan and testing strategy
  • Toxicological exposure and safety assessment according to ISO 10993-17 and ICH guidelines
  • Toxicological support for material selection or substitution projects
  • Planning, execution and evaluation of biocompatibility and chemical characterisation studies
  • Toxicological expert support for evaluation of active substances, critical substances or in case of non-conformities 
  • Evaluation of chemical and biological equivalence to support the clinical evaluation according to MEDDEV guideline 2.7/1 rev. 4

Novel device or existing product

Whether you have a device on the market or you are developing a novel concept, we can support you in finding the best strategic solution to ensure adequate and compliant documentation for biocompatibility and toxicological safety.

For novel devices aiming at CE marking and regulatory clearance, we can assist you with planning and execution in all stages of the development. We can particularly guide you during the design verification and design validation phases.

For marketed devices, we assist with tasks concerning the product life cycle, including update of documentation or changes in design, materials, manufacturing or sterilization.

 

Chemical characterisation and toxicological assessment

Requirements in ISO 10993-1, ISO 10993-17 and ISO 10993-18 

Providing detailed physical and chemical information on materials and chemicals is mandatory in ISO 10993-1. Chemical characterisation and chemical analysis data must be embodied in the Biological Evaluation Report to document the level of migrating substances, impurities, degradation products or contaminants. 

It takes expertise to interpret the results from chemical characterisation and analysis studies and to assess biological and toxicological risks. We have many years of experience in performing toxicological exposure and risk assessment, as well as access to data sources data and in silico prediction of toxicological effects and limits.

Requirements for chemical characterization

The requirements for chemical characterisation are set forth in ISO 10993-18:2009 and a new version with significant updates is expected in 2019. In addition, chemical characterisation and chemical analyses are often requested in connection with regulatory clearance by the US FDA, Chinese or Russian authorities. Therefore, a sound strategy for chemical characterisation and chemical analysis data is important when you want to ensure compliant regulatory submissions.

How we can help you
We are very experienced in using chemical analyses to assess the risk of toxicity or biological effects of medical devices. We collaborate with contract research organisations (CROs) and can help you find the right laboratory for testing of a device or material. Our expertise covers a range of materials including polymer materials, metals, textiles, as well as creams and formulations containing active substances.