In February 2014, the MHRA published new guidance on borderline medical devices.  The guidance considers only medical devices within the terms of the Medical Device Directive and not the Active Implantable Medical Devices Directive or In Vitro Medical Devices Directive.

Purpose and mode of action

The MHRA makes clear that borderline determinations “will be based on the stated intended purpose of the product and its mode of action.”  The intended purpose will be determined by the labelling, instructions for use, and promotional material for the medical device.  However, the governing factor in assessing whether a product is a medical device or medicinal product is the mode of action of the product concerned.

Application to products

The guidance provides examples of borderline devices across a number of categories, including medicines, sport and leisure products, personal protection equipment, software, machinery, spare parts, second-hand devices, and custom-made devices.

The guidance makes clear that:

  • Products that are not specifically intended for a ‘medical purpose’ are not considered medical devices even if a secondary purpose of the product is the prevention of disease, e.g. muscle toning products or slimming products are not normally medical devices but muscle toning products with medical claims (such as treating incontinence) or slimming products indicated for treating clinical obesity that are not medicinal products may be considered medical devices.
  • Products that have multiple purposes, which may occasionally be used within a medical environment, are not normally medical devices unless a manufacturer assigns a specific medical purpose to such products.
  • The determining factor for deciding if aids for daily living are medical devices is whether there is a direct link between the corrective function of the equipment and the individual concerned and that there is a stated medical purpose e.g. baths with integral hoists, mobility aids for the visually impaired, and wheelchairs are normally medical devices but acoustic signals at traffic lights, baths with doors, and stair lifts are not usually medical devices.
  • Sports or leisure products are not generally considered medical devices.  However, products that make specific claims for the treatment of pain or injury may be considered medical devices e.g. heat/cold pads for pain relief, support bandages, or gym equipment placed on the market specifically to measure a physiological function.  Gym equipment that contains an element to measure heart rate for example is not a medical device as the primary purpose of the equipment is fitness rather than measuring physiological functions.

Standalone software or software used in combination with a device which is ‘intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes’ may be a medical device, e.g. software intended to enhance images from x-ray or ultrasound may be deemed to be a medical device but a patient management system or a records storage system is unlikely to be a medical device.

Products falling outside the medical device regulatory regime may still be covered by the Consumer Protection Act and must be safe for their intended purpose.