Medical Devices Regulatory Pathway Download

The Importance of Chemical and Material Characterization

Whether increasing efficacy and reliability, reducing manufacturing costs, or delivering the highly personalized devices of the future, the medical devices industry depends on materials science to deliver products that are fit for their intended use and that also meet both regulatory and performance requirements.

The timeline for bringing a medical device to market can average anywhere between 3 to 7 years and requires manufacturers to navigate through a complex regulatory framework. While this framework is intended to safeguard patient safety, the regulations and standards that support them have historically been surprisingly outdated
and fragmented.

In helping manufacturers achieve a more robust level of compliance that is aligned with today’s materials advancements, regulators across Europe are updating three decades of regulatory history
by replacing a series of existing medical device directives with a more comprehensive set of regulatory guidelines captured under the EU Medical Device Regulations (EU MDR). Through the introduction of the EU MDR, regulators are aiming to strike a balance between the risk associated with medical devices and their benefit to society.

The goal of the EU MDR is therefore centered around establishing a series of risk-management strategies that help ensure that medical devices reach patients as soon as safely possible. In doing so, manufacturers and their suppliers will need to work closer than ever before in understanding the risk across the entire value chain – from raw materials to the finished product itself.

In contrast to previous regulatory requirements, the EU MDR regulations establish a need for organizations to better understand potential risks, beginning with deeper insight into the chemical properties of materials themselves. For medical device manufacturers, accelerating product commercialization and protecting the value of their brands will continue to be critical factors in remaining competitive within the marketplace.

As new regulatory requirements are introduced, adopting a more thorough approach into chemical and material characterization can be the essential ingredient in securing a first-to-market advantage through both innovation, safety, and regulatory compliance.

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