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Requirements for companies and products in the life sciences and medical device sectors are constantly evolving. In the EU, they are closely linked to legislation regarding chemicals (REACH), electronics (RoHS), and biocides, as well as environmental considerations. EU regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR) prioritize product safety and performance, with a strong focus on requirements for materials in contact with medical products.
We can help you meet requirements for safe products and navigate regulatory challenges in the EU and globally.
At DHI, we can assist with:
With in-depth knowledge of EU regulations for medical devices (MDR), in vitro diagnostic devices (IVDR), and chemicals (REACH), we can help you meet requirements regarding regulatory toxicology, biocompatibility, and chemical substance documentation. In addition to extensive knowledge of regulatory requirements in the EU and the USA, we are familiar with the requirements in Japan, China, South Korea, Brazil, Mexico, and Russia.
Leveraging our expertise in toxicology and biocompatibility, we can assist you in preparing biocompatibility reports and summarizing documentation for inclusion in technical files or registration dossiers. We can also help address inquiries from Notified Bodies regarding CE marking or from national authorities, including specific local registration requirements.
US FDA regulations entail a number of specific requirements for biocompatibility documentation beyond those set out in ISO 10993-1. We have practical experience with these requirements and have participated as experts in pre-approval processes and 510(k) clearances, as well as serving as toxicology experts for the FDA.
Our solutions are flexible and tailored to your needs:
We collaborate with partners specializing in quality assurance, design control, risk management, biological testing, chemical analysis, verification and validation, and clinical affairs. We offer advice on comprehensive solutions for MDR or IVDR compliance.
Examples of projects we have completed:
Marketing medical devices, combination products, or in vitro diagnostic devices can be a complex task. In addition to the requirements for medical devices, you must also comply with chemical legislation and be able to provide information regarding the manufacture, import, export, and transport of products, chemical substances, and raw materials.
In this context, one must be aware of specific requirements regarding labeling or the disclosure of ingredients. This applies, for instance, to substances under REACH legislation that are of particular concern (SVHCs) or substances covered by California’s Proposition 65 legislation.
Under the MDR, manufacturers are required to label certain types of medical devices if they contain more than 0.1% of a chemical with an EU-harmonized classification as carcinogenic, mutagenic, or toxic to reproduction (CMR substances), or if the chemical has endocrine-disrupting properties.
It is important to stay up to date with changes in regulatory requirements. Drawing on our experience with chemical regulation, we can help you comply with both local and global regulations and compile the necessary documentation.
We can assist with:
Leveraging our extensive toxicological expertise and knowledge of chemical properties, we can assist you in replacing chemicals that pose risks to human health or the environment. This includes substances that are endocrine disruptors or subject to restrictions due to their harmful effects (CMR substances).
Grounded in chemical legislation, we provide advice on regulatory requirements and potential strategies if your company uses chemicals that must be phased out, substituted, or require authorization for continued use to ensure compliance with REACH, RoHS, or MDR GSPR 10.4 regulations.
Together with our partners at EPPA, we have experience assisting companies in applying for authorization for the continued use of chemicals listed on the REACH Authorization List (Annex XIV) or for the extension of RoHS exemptions. Such measures may be necessary when substitution is not technically feasible or would require several years to implement.
The latest update to ISO 10993-1 (2025) establishes new requirements for assessing and documenting the biocompatibility and safety of medical devices. This includes, among other things, new criteria for categorizing contact and contact duration, characterization and requirements regarding physical and chemical data, as well as information on which biological tests are relevant for safety assessment.
US FDA regulations and those of a number of other countries are moving towards including ISO 10993-1:2025 in their lists of recognized standards. ISO 10993-1:2025 is expected to be approved as a harmonized standard in the EU, thereby becoming a determining factor for requirements under the EU Medical Device Regulation (MDR).
Updating the ISO 10993 series is an ongoing process. We are actively involved in this work and thus fully up to date with requirements and best practices; our expert toxicologist is certified as a European Registered Toxicologist (ERT) and a Diplomate of the American Board of Toxicology (DABT).
Get assistance with:
Compliance with ISO 10993-1, ISO 10993-17 og ISO 10993-18
ISO 10993-1 requires that biological evaluation be based on detailed information regarding the materials and substances in the product, as well as their physical and chemical properties. Chemical characterization and chemical analysis data must be included in the biological evaluation report to document the levels of leachables, impurities, degradation products, and contaminants.
We possess the expertise required to evaluate chemical characterization analysis results and to assess biological and toxicological risks. We have years of experience conducting exposure and risk assessments and have access to extensive data sources and in silico predictions of toxicological effects.
Requirements for chemical characterization are set out in ISO 10993-18:2020. Chemical characterization and chemical analyses are often required for regulatory approvals in the USA, China, and Russia. Therefore, it is important for your company to have a strategy for chemical characterization and chemical data when applying for approval.
We have extensive experience in using chemical analyses to assess the risks or biological effects of medical devices. We collaborate with established contract research organizations (CROs) and can help you find the right laboratory for testing your devices and materials. Our experience covers a wide range of materials, including polymers, metals, and textiles, as well as creams and formulations containing active ingredients. This enables us to assist you in selecting the appropriate analyses and tests - independently of advice provided by the laboratories.
