Important Update for UK Assistive Technology Providers!
The UK government has revised its guidance regarding which assistive technologies qualify as medical devices, necessitating a conformity assessment. Assistive technology includes innovative products and systems designed to support individuals with disabilities, mobility restrictions, or impairments, making challenging tasks more manageable.
Wondering if your product qualifies as a medical device? The key factor is whether there’s a direct link between the product’s corrective function and its intended user. Despite similar functionalities, the classification as a medical device depends entirely on the manufacturer’s claims for the product.
Examples of assistive technologies that are likely considered medical devices include:
1. Baths with integrated hoists
2. Communication aids
3. Monitors for epilepsy and enuresis
4. External limb prostheses and accessories
5. Hearing aids
6. Orthopaedic footwear and various orthoses
7. Patient hoists
8. Products for pressure and posture management
9. Mobility aids such as slider boards, standing aids, frames, crutches, and wheelchairs, including powered ones
10. Mobility scooters
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