There are more than half a million different medical devices on the European market. When the USA and APC regions are also taken into account, the diversity of medical devices, and not forgetting in vitro diagnostics around the world, runs to millions of different products.

For the university academic team, a SME company developing a medical device/diagnostic for the first time, or a company strategically growing sales through entering a new geographical market, the regulatory landscape can be bewildering.

In general, the first step for a medical device is to determine whether it has an intended ‘medical purpose’, meaning that the product will need to comply with medical device regulations. The risk that the product has to be carefully evaluated. For example, is the product supplied sterile, does it provide a critical measure or 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? Does the device rely on energy such as battery power or electricity, involve radiation? Is it a piece of software such as an app, that provides clinical direction, or is the software embedded inside a piece of equipment? Does that software utilise ‘machine learning’ or ‘artificial intelligence’?  These questions are just some of those that need to be answered, helping to define what the product is around its intended purpose, its potential risk to the patient or user, and thereby providing the stage for what will be required to demonstrate the clinical safety and effective of the product.

With respect to in vitro diagnostics, most people will have become acquainted with COVID19 testing (SARS-CoV-2) and the terms LFT and PCR since 2020. At the outset, these tests were categorised as ‘low risk’ but the potential impact on a population of people if a test was inaccurate, could have devastating consequences. As a result, the COVID19 tests have become elevated to Class D, the highest risk group, under the recent European In Vitro Diagnostics Regulation. 

Here at InViva, we have been part of the global medical ecosystem for more than 30 years and have extensive knowledge of past and present technologies. We have partnered in the development of new devices that include medical robots, hip implants, millimetre scale minimally invasive surgery, wound care diagnostics and a device for cleaning wounds like maggots do….but without the maggots. 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.

Looking to the future, in 2023 we are partners in one of the most advanced projects of its kind, in the world, working with research active transplant surgeons, the National Health Service, and leading academics from top UK universities recognised for pioneering work in Artificial Intelligence. The aim is to deliver a revolutionary technology for use in the operating theatre, with the potential to save hundreds of lives across the world through speedy diagnostic support.