The new EU Medical Device Regulation (MDR) 2017/745 and in vitro Diagnostics Regulation (IVDR) 2017/746, with an application date of 26 May 2020 for medical devices and 26 May 2022 for in vitro diagnostics, increase the quality and safety requirements for medical devices. Medical devices that come into direct or indirect contact with the human body must be biocompatible. The ISO 10993 standards provide an internationally harmonized system for assessing and optimizing the biological safety evaluation of medical devices.
ToxHub, with its European Registered Toxicologist (ERT), will assist your company to meet your goals, by offering you a complete set of solutions ranging from feasibility analysis and biological evaluation reports to effectively and efficiently meet the requirements of the Regulations on Medical Devices.
ToxHub will support medical device manufacturers in achieving compliance with the new EU regulations and other major markets around the world regarding the safety and the biocompatibility of the product and assuring the health and safety of patients.
We can help you by offering the following services:
- Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER), within a risk management process in accordance with ISO 14971:2019;
- Gap analysis to the ISO standards;
- Mixture MD Raw Materials toxicological characterization and safety assessment (biological evaluation process-Material characterization) according to EN ISO 10993-1:2009 and subsequent modifications, following the process of an in-depth literature review as indicated in Annex C to the ISO;
In particular the following activities are proposed:
Toxicological evaluation of MD Raw Materials and its constituents.
Risk assessment on absorption, penetration and local distribution of devices composed of substances, or of combinations of substances, that are intended to be introduced into the human body via a body orifice or applied to the skin as required by Rule 21 of Regulation (EU) 2017/745. Assessment of systemic exposure for the identified use. Calculation of safety margins.
Toxicological risk assessment of residual impurities from the manufacturing process (ISO 10993-18), degradation products (ISO 10993-13/14/15) and substances extracted and/or released by the primary packaging in the MD (ISO 10993-17) including polymers (plastic/silicon), solvents, elemental and genotoxic impurities and definition of their safety limits.
In silico assessment (QSAR modelling, analogue identifications and read across justification) of toxicological endpoints for data-poor substances, for the definition of safety limits of contaminants using commercial tools such as Lhasa and Leadscope. The ICH M7 approach will be followed for the evaluation of genotoxicity potential. Other endpoints (e.g. skin sensitization) will be evaluated following a step-by-step approach (services provided by partners).
Guidance-compliant screening for endocrine disrupting properties.
- Biocompatibility Test Plan strategy development following 3R principles, using in vitro models, avoiding animal testing and time wasting;
- Study design, outsourcing, monitoring and evaluation (including risk assessment) of studies at contract research organisations (CROs);
- Interpretation of results obtained in biocompatibility and safety assessments (interpretation of biological evaluation data and overall biological safety assessment) in accordance with EN ISO 10993-1:2009 and subsequent amendments;
- Writing the toxicology sections of the regulatory documentation / biocompatibility plan;
- Feasibility and safety screening of new technologies including botanicals and nanomaterials;
- Due diligence evaluation of new business ventures;
- Customized external training on the ISO 10993 standards.