Therapeutic Devices

Therapeutics devices means devices, appliances, or related accessories that correct or treat a human physical disability or surgically created abnormality.

What is a Therapeutic Device?

A therapeutic device refers to any device or product that aims to provide a therapeutic benefit, which typically means alleviating or treating a medical condition. The key distinction here is that not all therapeutic devices are classified as medical devices, as they may not have a strictly medical purpose as defined by MHRA regulations.

Therapeutic devices may include products that:

• Provide comfort (e.g., heating pads, compression garments).
• Assist with physical rehabilitation (e.g., braces, massage tools).
• Promote well-being (e.g., stress relief gadgets, sleep aids).

Some therapeutic products, like non-invasive wearables, might offer health benefits without directly treating or diagnosing medical conditions. This can cause overlap in categorisation, as therapeutic claims may suggest a medical use, potentially making the product fall under medical device regulations.

Are Therapeutic Devices Considered Medical Devices?

Not necessarily. A therapeutic device is only considered a medical device if its primary intended purpose aligns with one of the medical purposes outlined above. The key criterion for determining if a device is classified as medical lies in its intended use and how it is marketed. A device advertised for improving general well-being or comfort without any specific medical claims may not be classified as a medical device, even though it could provide therapeutic benefits.

For example, a fitness tracker that monitors heart rate might not be classified as a medical device if it is marketed primarily for fitness and wellness purposes. However, if the same device were marketed for diagnosing or monitoring heart conditions, it could be subject to medical device regulations.

Key Differences Between Medical and Therapeutic Devices

1. Intended Purpose: Medical devices are specifically designed and intended for diagnosing, treating, or preventing medical conditions, whereas therapeutic devices may simply promote general health or comfort.
2. Regulatory Requirements: Medical devices must undergo rigorous assessment for safety, effectiveness, and quality before they can be marketed in the UK. This includes compliance with the UK Medical Device Regulations 2002 and the new UKCA Marking for Medical Devices for devices post-Brexit. Therapeutic devices, particularly those not intended for a medical purpose, may not need to meet these stringent requirements.
3. Classification: Medical devices are classified into different risk categories (Class I, IIa, IIb, III) based on their potential impact on health. The higher the risk, the more stringent the regulatory requirements. MHRA outline the classifications of medical devices based on risk. Therapeutic devices that do not meet the medical device definition often fall outside this regulatory classification.