Choosing the right manufacturing materials for medical devices – from the start of the development phase – is crucial to protect the safety of users. Not only that, there is also a need to ensure that chemical substances used to manufacture the devices comply with regulatory standards.
Placing medical devices on the market requires extensive knowledge of global regulatory requirements to stay clear of the ambiguities
However, many are not aware of the potential complexities of fulfilling the different regulatory requirements, such as the new Medical Device Directive (MDR), the In Vitro Device Directive (IVDR) and the REACH regulation.
Documenting the safety of medical devices – what has changed?
Human safety is a key issue in the new MDR and IVDR, which will come into force in the EU in 2020. This significantly increases the requirements for documentation of medical devices and of the substances used to manufacture them.
Medical devices may also be subject to the REACH regulation. REACH regulates the use of chemical substances in the EU and this may have impact on your choice of material and substances for your devices.
What is REACH?
REACH stands for the Registration, Evaluation, Authorisation and Restriction of Chemicals. The regulation aims to protect human health and the environment through better and earlier identification of the intrinsic properties of chemical substances. REACH also calls for substitution of substances of very high concern (SVHC) with suitable alternatives. SVHCs are substances that may be classified as hazardous to human health and/or the environment.
Why you must choose the right material early in the R&D phase
A medical device manufactured in the EU may contain a problematic substance that is subject to authorisation in REACH. If a substance is included in the Authorisation List only due to its health effects, authorisation is not required as health and safety is assessed in connection with the MDR.
However, if a substance is on the list because of its environmental hazards, you must obtain an authorisation for continued use. This comes as a surprise to many manufacturers.
There are many such overlaps and ambiguities to unravel. Consequently, choosing the right material is pivotal in the development phase. Just because a material contained in a medical device has the right technical properties, it does not mean it has complied with the regulatory demands.
Our most important advice to manufacturers is to assess the toxicity of the materials and chemical substances you want to use as early as possible. This may spare you undue delays later in the process.
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About the author
- Senior Toxicologist, European Registered Toxicologist (ERT), DHI Denmark | Brian’s focal point is his in-depth expertise in human toxicology coupled to the regulatory requirements for use of chemicals in industry and in pharmaceuticals and medical devices. Another area of interest is the use of computer modelling, such as in silico and QSAR, to model pharmacologic or physiologic processes in order to avoid testing on animals.