Does your device require a clinical investigation?
Are you developing a product intended to diagnose, treat, or prevent medical conditions? If so, there's a good chance that your innovation is classified as a medical device in the EU. In this blog post, we take a look into why categorization matters on your product's journey from concept to market.
The term 'medical device' typically brings to mind the equipment found in hospital settings. However, the European Union Medical Device Regulation (MDR) shows that the spectrum of medical devices extends well beyond this. At times the lines can blur, leaving manufacturers wondering whether their product is considered a medical device or not.
If a product qualifies as a medical device, it must meet the requirements of MDR regulations to be sold in Europe. Moreover, clinical investigations are mandatory for high-risk and innovative medical devices, and obtaining a CE mark is essential for any device aiming to enter the EU market. As the MDR affects the whole product development process, accurate categorization will save your team from many major setbacks down the road.
What is a medical device according to MDR?
MDR article 2 defines a medical device as any instrument, apparatus, appliance, software, implant, reagent, material, or other article that is used for any of the following:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease,
- Diagnosis, monitoring, treatment, alleviation of the consequences, or compensation for, an injury or disability,
- Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.
Based on the potential risk of harm to users, MDR divides medical devices into four classes: Class I, Class IIa, Class IIb, and Class III, with each class requiring a different level of regulatory control. The risk classes are described in MDR article 51.
Despite the detailed definitions and classification system, the increasing number of borderline products is complicating the categorization process.
Examples of medical devices
As the MDR states, the intent of use plays a major role in defining which category the product fits. Overall, there are more than 500,000 types of medical devices on the EU market.
Stethoscopes, infusion pumps, surgical gloves, and hospital beds are classic examples of medical devices. In addition to hospital machinery, a broad array of home-use products also must comply with the MDR, as they are designed to treat, diagnose, or prevent medical conditions. These include devices such as blood pressure monitors, insulin pens, hearing aids, and contact lenses. Additionally, implants and medical software are among the growing product categories in the medical device market.
The difference between a medical device and a wellness device
In everyday language, medical devices are often conflated with another expanding product category: wellness technology. While both serve health-related purposes, wellness devices are designed to promote general well-being rather than treat medical conditions. As a result, they do not require CE marking.
Software as a medical device
MDR also applies to any software that is intended to be used for a medical purpose and meets the definition of a medical device. Think of the purpose: If the intended use of your app is, for example, to prevent or predict an outbreak of diabetes in the patient, it can fall under the category of medical devices. However, this classification needs to be studied individually for each software solution.
Clinical investigations are usually mandatory for launching your medical device in the EU, but navigating the complex terminology can be overwhelming. Simplify your journey with our free online course, Clinical Studies 101! It is designed to help startups, R2B teams and others working with medical devices and wishing grow their knowledge.
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