What is a Medical Device ( Deffinition)

Introduction

The phrase ‘assistive technology’ is often used to describe products or systems that support and assist individuals with disabilities, restricted mobility or other impairments to perform functions that might otherwise be difficult or impossible. An assistive technology product can be classed either as a medical device, which needs a CE mark and is regulated by the applicable legislation or it can be an ‘aid for daily living’. It depends on the claims made by the manufacturer.

Just because a product is used in a healthcare environment or by a healthcare professional, does not automatically mean it is a medical device. It will only be considered a medical device if the manufacturer has stated it has a medical purpose and if the product’s primary mode of action is physical or mechanical.

Although we work closely with competent authorities in other member states in the European Economic Area, views on whether an assistive technology product is considered a medical device can sometimes vary between countries. This means that similar products manufactured in different EU member states may be regulated differently depending on the views of that country’s competent authority. Due to the complexity of the medical devices legislation, MHRA will always consider each product on a case-by-case basis when giving advice.

2. Definitions

2.1 Medical device, as defined in the Medical Devices Directive 93/42/EEC*

‘…means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

diagnosis, prevention, monitoring, treatment or alleviation of disease
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
investigation, replacement or modification of the anatomy or of a physiological process
control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its functions by such means.’

This guidance relates to the Medical Devices Directive 93/42/EEC and is not intended to cover the definition or scope of the new Medical Devices Regulations 2017/745, which will come fully into effect in May 2020. We may update this guidance to reflect the new regulations.

2.2 Medical purpose

Medical devices are products which are primarily intended to be used for a medical purpose. The manufacturer will state the medical purpose of their product in their labelling, instructions for use or service manual and promotional material.

2.3 Primary intended purpose

Some products may have various purposes. For example, a commode, which is intended to be used by individuals with disabilities or mobility issues, may be considered to have a toiletry purpose or a medical purpose. A commode is primarily intended to be used for toiletry purposes rather than a medical purpose, therefore it would not normally be considered as a medical device.

3. Assistive technology: medical device or not?

Equipment intended for alleviation of, or compensation for, a disability may or may not be a medical device. The determining factor will be whether there is a direct link between the corrective function of the equipment and the individual concerned. This is based on the product’s primary intended purpose as defined by the manufacturer. Although two products may appear to be similar in function, one may be a medical device whilst the other is not. It depends entirely on the claims made by the manufacturer for each product.

3.1 Example

A manufacturer sells 2 different kinds of portable wheelchairs: a self-propelled wheelchair intended for use by people with disabilities or difficulty in walking and another that is intended to be used by hospital porters to transport patients around the hospital.

The first is a medical device because there is a clear link between the corrective function (compensation for injury or disability by providing a mode of transportation) and the individual (persons with disabilities or difficulty in walking).

The second wheelchair is not a medical device because although the purpose is also to provide transportation, it is not specifically intended to be used only by those with disabilities or difficulty walking. It is an aid for the porter to transfer anyone around the hospital quickly and safely.

Examples of medical devices:

baths with integrated hoists
epilepsy / enuresis monitor
external limb prostheses and accessories
communication and hearing aids
orthopaedic footwear
orthoses (lower/upper limb, spinal, abdominal, neck, head)
patient hoists
standing aids
walking / standing frames
walking sticks / crutches
wheelchairs (including sport models)
posture management (from simple cushions to complex support systems)
pressure management (pressure redistribution/relief cushions and mattresses)
slider boards

3.2 Regulation

Under the medical device regulations most AT devices are class I or custom made medical devices. They may also be manufactured in-house by healthcare establishments rather than bought from manufacturers.

4. For one or for all?

The distinction between intended use by specific individuals and ‘by all’ is a key factor when considering whether a product is a medical device. Unless a manufacturer specifies that a product is intended to be used by individuals for a stated medical purpose, the product could be used by anyone, regardless of whether they have a medical condition. If a product can be used by anyone then it is unlikely to be a medical device.

4.1 Example

Walking sticks which are intended to be used by those who have difficulty walking or other mobility issues are generally considered to be medical devices because they have a clear medical purpose and a clear link between the corrective function (to aid mobility) and the individual (person using the walking stick).

However, walking sticks which are intended for recreational use (i.e. hill-walking or mountaineering) would not be considered medical devices because they do not have a clear medical purpose and can be used by anyone, regardless of whether the individual using the stick has mobility issues or not.

4.2 Example

Cushions which are intended to relieve pressure and prevent pressure sores for use by wheelchair users who spend long hours sitting in the chair would likely be considered to be medical devices because they have a clear medical purpose and a clear link between the corrective function (to relieve pressure and prevent pressure sores) and the individual (wheelchair user).

However, ordinary cushions (including those used in hospital or healthcare environments) would not be considered medical devices because their primary purpose is for comfort rather than medical and they can be used by anyone.

4.3 Aids for daily living – not medical devices

There are many products that help people carry out day-to-day activities. Although they may be used by those with disabilities or other impairments, in healthcare environments or by healthcare professionals, many of these products may be used by anyone and will not have a specific medical purpose or direct link to the individuals concerned. Such products are usually referred to as ‘aids for daily living’ and are not medical devices. For example:

acoustic signals at traffic lights
bariatric chairs and stools
bath with easy access door
chair riser
grab rails (at doorways, stairs, beds etc.)
personal alarm systems (including fall alarms)
portable ramps, wheelchair vehicle restraints
rise and recline chairs
shower chair
special water taps
stair lifts
toilet equipment (toilets seats, shower seats, commodes)

Again, it is important to note that just because a product is used by individuals with disabilities or other impairments and has the CE marking logo, does not necessarily mean it is a medical device. For example, white sticks used by people who are blind or visually impaired are likely to be regulated as Personal Protective Equipment (PPE) as they do not actually help the user to walk, bur rather they act as protection while the user is moving. Hip protectors for prevention of injury for those at risk of falling would also be likely to come within the remit of the PPE regulations. Such products are likely to be CE marked under PPE rather than medical device legislation.

View MHRA guidance on borderlines with medical devices.

If you have a problem with such a product, please contact your local Trading Standards Office. The Office for Product Safety and Standards provides information on consumer recalls.

5. Safety issues

5.1 What can go wrong

Problems with an assistive technology device may include:

inadequate repair or maintenance instructions from the manufacturer
poor or lack of training in how to use/repair/maintain the device
inappropriate local modifications/adjustments
inadequate maintenance process
inadequate or inappropriate repairs/replacement parts
problems from storage/use conditions
inadequate end-of-life/scrapping information from the manufacturer or provider
incompatibility or the lack of compatibility information with other devices
problems with the device itself:
- failure of the device, e.g. cracks, leaks, detachments
- design
- production
- packaging
device documentation (e.g. instructions for use, technical/operation manual etc.):
- not complete
- confusing
- not with the device
non-CE marked devices that are supplied to the UK
aids for daily living that are marked as medical devices in the UK

6. What to do with a failed device

If you are a personal user:

do not use the device if you are worried about its safety, for example if it doesn’t feel safe to use as described in the instructions
contact your healthcare professional if you were given the device by them or if not, contact the retailer or manufacturer

If you are a professional user:

quarantine the device
contact the manufacturer and request them to collect and analyse the device

7. What to do next

Report suspected or actual adverse events involving medical devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

MHRA reviews all incident reports. The more incidents received, the more likely it is that appropriate corrective actions are taken by the manufacturer to improve safety. Sometimes, a single report can lead to corrective action.

8. What happens to your report

It is:

reviewed
given an investigation grading and added to our database

Reports are actively investigated when:

they are reports of death or serious injury

the manufacturer’s investigation indicates a wider problem

MHRA detects a pattern in reported problems. This is called signal detection

MHRA will always:

tell you, within 10 working days of receipt of your report, what we plan to do
send your report to the manufacturer for their internal investigation. Your details are only supplied if you have agreed to this on your report
request the manufacturer to review and if they investigate, to provide details of their findings
review the manufacturer’s findings

When the manufacturer carries out an investigation, please provide them with any details they request.

9. Why you should report

To:

fulfil your duty of candour (if you are a healthcare professional)
first identify a device issue of national significance, or to help to trigger a cascade of corrective actions
help form a full picture of issues experienced in the UK
improve quality of clinical/care services to users
prevent serious harm to others

9.1 Examples of actions taken following reported incidents

A report of a drive wheel detaching from a powered wheelchair whilst in use resulting in the chair tilting to one side:

key things were missing from the technical manual and the manufacturer corrected it
the manufacturer issued a Field Safety Notice (FSN) and MHRA issued a Medical Device Alert (MDA) to make sure users were aware of the problem

MHRA identified an emerging trend in handle fractures of a walking stick. As a result, the manufacturer:

issued an FSN to customers, giving the instruction to remove and destroy affected devices from use
made changes in the device production and implemented a new testing routine

A patient died after falling out of a sling during transfer from a bed due to a clip disconnection:

the manufacturer issued an FSN to remind users of the importance of doing a risk assessment before using the sling for the first time and carrying out pre-use checks
the manufacturer updated the instructions for use of the sling
MHRA published an MDA