PROFILE
Helping medtech developers make the right decisions Article by Charlotte Strøm
At DHI experts in toxicology advise the medtech industry on developing tomorrow’s medical device that meets impending EU regulation. The new EU regulations (the Medical Device Directive (MDR) and the In vitro device directive (IVDR)) increase requirements for documentation in medical devices. The directives are expected to come into force in 2020 and 2022 respectively, but for medtech developers the implications of the regulation already affect operations and
of materials and chemical constituents such as additives, residual monomers and metabolites. Moreover, we investigate impurities and degradation substances in order to optimise the safety aspects of medical devices, he says. Brian Svend Nielsen gives an example: -It could be selection of rubber or plastic
Improved patient safety
development projects. -When you are in the early phase of development, the most vital decision to make is the right choice of material. Consequently, careful consideration must be given to selection of materials and chemical constituents with regard to toxicity, Business Development Manager at
material for a tube or a pumping system that will carry medicine. Several issues must be addressed, such as potentially migrating substances and their toxicity. Moreover, a careful assessment needs to take place in order to avoid or minimize use of substances classified either as mutagenic, carcinogenic or reprotoxic
The new MDR and IVDR also require each device to be registered with a unique identification tag. -There will especially be an increased control with use of substances having carcinogenic, mutagenic, reprotoxic, or endocrine disrupting properties. For some types of medical device even very small
DHI, Brian Svend Nielsen says. He is a senior toxicologist and helps medtech developers and manufacturers optimize their choice of material, enabling a cost-efficient development as well as ensuring minimized negative effects on human health.
(CMR), for instance classified phthalates in polyvinylchloride (PVC). He continues, -If the medical device has just the right texture to fulfill its purpose, using substances that are identified as being endocrine disrupting chemicals (EDC), then you will inevitably run into problems as a manufacturer with the new regulation. But – there are alternatives, and at DHI we have the expertise to help medtech companies working their way through this jungle.
amounts of these substances have to be labelled, Brian Svend Nielsen ends
-With our extensive knowledge of toxicity of chemicals and experience with REACH (Registration, Evaluation, Authorisation and Restriction of Chemical substances) and global chemical regulations, we provide safety assessments
Brian Svend Nielsen points to the increased control as a clear patient benefit, primarily on safety. -This will clearly raise the demands among the medical device developers and manufacturers, he says.
Facts about DHI and services in medical devices •
Biocompatibility evaluation and documentation
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Regulatory support for global market access
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Intelligent test strategies and data mining
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Read-across strategies, QSAR and in silico models to predict toxicological end points.
For more information on our services within product safety, environment and toxicology: http://www.tox.dhigroup.com
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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017