Access to medical equipment to meet chemical regulations

Access to medical equipment to meet chemical regulations

Choosing the right building materials for medical devices – from the beginning of the development phase – is critical to protecting the safety of users. Not only this, there is also a need to ensure that the chemical substances used to manufacture the equipment comply with the regulatory standards.

Keeping medical devices in the market requires a comprehensive knowledge of global regulatory requirements to stay away from ambiguities

However, many are not aware of the potential complications of meeting various 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 security 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 the substances used to manufacture them.

Medical devices may also be subject to access regulation. REACH regulates the use of chemical substances in the European Union and this may have an impact on your choice of materials and substances for your equipment.

REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals. The regulation aims to protect human health and the environment through better and earlier detection of the intrinsic properties of chemical substances. REACH also calls for replacement of Extremely High Concern Substances (SVHC) with suitable alternatives. SVHCs are substances that can be classified as hazardous to human health and/or the environment.

Why you should choose the right material in R&D stage

A medical device manufactured in the European Union may contain a problematic substance subject to authorization in access. If a substance is included in the authorization list simply because of its health effects, authorization is not required as the health and safety assessment is carried out in relation to the MDR.

However, if a substance is on the list because of its environmental hazards, you must obtain an authorization for continued use. This comes as a surprise to many manufacturers.

There are many overlaps and ambiguities that have to be resolved. As a result, it is important to choose the right material at the development stage. Just because a material contained in a medical device has the correct technical properties, it does not mean that it has complied with regulatory demands.


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Brian Svend Nielsen, Principal Toxicologist, European Registered Toxicologist (ERT)

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