The Podiatry Drill as a medical device

In a few words: What is a medical device?

Medical devices are clearly defined products which, according to the European Medical Devices Regulation (MDR), have a medical purpose – they aid in diagnosis, alleviate or treat diseases. These products must be legally certified and tested, and are accompanied by a declaration of conformity. The CE mark with a four-digit number indicates that a notified body was involved in the testing – typically for higher-risk products. Find out more in our blog post 'Medical devices in podiatry: What you should know as a podiatrist'.

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Who is required to use medical devices?

Podiatrists are members of the healthcare professions. They treat patients for medical purposes, for example under the Prescription of Medicines Act (HMV). They are therefore required to use medical devices in their practice.
Foot care professionals, on the other hand, treat only healthy feet and are permitted to use beauty products. However, it is recommended that certified equipment be used in beauty salons as well, as this ensures a higher standard of safety and hygiene.

Why no non-medical devices in the treatment room?

Any podiatrist who uses a non-medical device during treatment automatically assumes the manufacturer’s liability. This has legal consequences in terms of liability. Without CE certification and a declaration of conformity, there is no product liability. If a patient is harmed by the use of a non-certified device, the person providing the treatment is personally liable (Section 16 MDR in conjunction with Section 2 MPDG).

Especially tricky: products that are only partially classified as medical devices.

For example, it can be the case that only the handpiece of a Podiatry Drill is classified as a medical device, whereas the drill itself is not. The risks to patients and practitioners increase, and here too, liability lies with the practice operator.

Our Quality Promise: Nova Pro

With the Nova Pro Podiatry Drill, you are receiving a fully certified Class IIa medical device – from the power source right through to the treatment tip. It meets the highest regulatory standards for safety, efficacy and hygiene.