Medical Device and In Vitro Diagnostics
For the university academic team, the small company developing a device/diagnostic for the first time, or the established company targeting a new geographical market, the diversity of medical devices and diagnostics can make the regulatory landscape difficult to navigate.
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Whether you are needing to understand the European Medical Device Regulation (EU 2017/745), the European In Vitro Diagnostic Medical Devices Directive (EU 2017/746) or the USA regulatory system overseen by the Food and Drug Administration (FDA), the first step is to determine – what does the product do? In other words, define the ‘intended purpose’.
For a device for example, is it supplied sterile, does it provide a critical measure, is it designed to be reusable? Does it contact the patient, or is it invasive in nature, possibly designed to be semi-permanently left in the body? Is it software such as an app? We then need to consider, what is the product’s risk profile?
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It is similar for in vitro diagnostics. Since 2020, most people have become familiar with LFT/PCR tests for COVID19 (SARS-CoV-2). Such a test was originally considered to have a ‘low risk’, but it is now classed as a ‘high risk’ diagnostic under the EU IVDR. That’s not because it represents a risk to the patient or user, but the consequences to the population if such a test was unreliable, giving incorrect information such as a ‘false negative’. It is therefore important to understand the product and the applicable regulations, to map the strategy towards certification e.g. the CE mark or UKCA mark.
InViva have been part of the global medical ecosystem for nearly two decades. We have learned, developing an organisational memory of well-established technologies and an understanding of the new, such as Artificial Intelligence and Machine Learning. We have partnered in the development of new devices for example: medical robots, millimetre scale minimally invasive surgery, wound care diagnostics and digital decision supporting Software as Medical Device (SaMD).
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Our skill is understanding the technology and translating the applicable parts of the regulations to focus time and budget effectively, for the devices and diagnostics to reach their target markets. Whether your product is a concept, with intellectual property that may be patented, or a mature technology that has a cost advantage for healthcare providers, we can help you.
