Substances of Concern

Substances of Concern and Nanomaterials

Substances of Concern

Medical devices are intended to improve health. Materials used for the production of medical devices, however, can contain – whether intended or not – substances or materials considered as nanomaterials or with the potential to cause adverse events, so-called substances of concern, such as carcinogenic, mutagenic and reprotoxic (CMR) substances or other critical materials.

In addition to specific regulations, medical devices produced or imported in the EU must also comply with the following regulatory requirements:

  • REACH Regulation (EC) No 1907/2006 (Registration, Evaluation, Authorisation and Restriction of Chemicals)
  • RoHS Directive 2011/65/EU (Restriction of Hazardous Substances in Electrical and Electronic Equipment)

With the growing political concern regarding the presence and use of endocrine disruptive substances (ED), on the one hand, and the lacking guidance how to evaluate their potential risks to human health and the environment, on the other, professional advice is becoming more important than ever. We can help you overcome your challenges related to substances of concern.

Our Solutions for Substances of Concern

  • Estimating the likely costs based on a data gap analysis, identifying missing studies and finding waiving opportunities through detailed and systematic database and literature searches
  • Regular monitoring of your raw material inventory in relation to new findings and regulatory changes
  • Developing tailor-made compliance strategies to meet your needs
  • Generating in silico data and performing knowledge- and statistics-based QSAR models to predict the activity, properties and toxicity of new or incomplete characterised substances based on the knowledge of their chemical structure
  • Planning, contracting and monitoring of laboratory studies
  • Applycation of EU guidelines on the benefit-risk assessment of the presence of phthalates
  • Establishing allowable limits for leachable substances in accordance with ISO 10993-17 by our experienced toxicologists
  • Dealing with specific requests to expert panels and competent authorities

Nanomaterials

Based on the new classification rule 19 in the EU Medical Device Regulation 2017/745, many medical devices need to be classified in higher risk classes if they contain nanomaterials. This is a complex task, especially because the current EU definition leads to ambiguity during testing when determining if medical devices contain or consist of nanoparticles. In addition, the potential for internal exposure is not clearly defined within the MDR, leading to additional uncertainty.

If nanomaterials are present, biological testing should be performed in line with the recent technical report ISO/TR 10993-22, published in 2017. With many labs having difficulties with implementing new test methods and several methods being defined within other ISO 10993 standards, nanomaterial testing remains nontrivial.

 Our Services for Nanomaterials

  • Characterisation of nanomaterials according to the latest standards and guidelines
  • Application of the nanomaterial definition and preparation of assessments to avoid higher classifications and additional tests
  • Professional handling of questions regarding internal exposure
  • Preparation of literature-based internal exposure assessments for your specific borderline products
  • Assistance with selecting biological tests and monitoring services to handle the specific complexity of the test execution

Whatever your specific needs, SCC helps to ensure your medical devices are fit for the future.