Medical devices: how to comply with the legal requirements in Great Britain

Active implantable medical devices

These types of devices are powered implants or partial implants that are left in the human body. Examples of active implantable medical devices include:

• implantable cardiac pacemakers
• implantable defibrillators
• leads, electrodes, adaptors for the above
• implantable nerve stimulators
• bladder stimulators
• sphincter stimulators
• diaphragm stimulators
• cochlear implants
• implantable active drug administration device
• catheters, sensors for item above
• Implantable active monitoring devices
• programmers, software, transmitters

Active implantable devices fall within the highest risk category in the classification system for medical devices.

In vitro diagnostic devices

This type of medical device is usually a:

• reagent
• reagent product
• calibrator
• control material, kit, instrument, apparatus
• equipment or system intended for use in vitro to examine specimens including blood and tissue donations from the human body

Other examples of in vitro devices are blood grouping reagents, pregnancy test kits and Hepatitis B test kits. See further guidance on the legislation relating to in vitro diagnostic devices for further information.

All manufacturers of IVDs must register their medical device with the MHRA..

General medical devices

These types of devices usually relate to most other medical devices such as:

• first aid bandages
• hip prostheses
• X-ray equipment
• ECG monitors
• heart valves
• dental materials
• spectacles
• depressors

How to comply with the legal requirements

If you are manufacturing a medical device, you must follow these guidelines alongside the relevant Part of the UK MDR 2002.

These regulations fall under the Consumer Protection Act 1987 and ensure medical devices meet the requirements so that they are acceptably safe to use and suitable for their intended purpose.

The route is different for custom made devices. See the guidance on custom made devices for more information.

Classification of medical devices

Medical devices are given a classification depending on the level of risk associated with them, for example the strictest control is for products with the highest risk.

General medical devices and active implantable devices

When you have established your product is a general medical device, you need to decide which class your device falls under. The categories are:

• Class I – generally regarded as low risk
• Class IIa – generally regarded as medium risk
• Class IIb – generally regarded as medium risk
• Class III – generally regarded as high risk

How a medical device is classified will depend on factors including the intended purpose of the device, how long it’s intended to be in use for and if the device:

• is invasive/surgically invasive
• is implantable or active
• contains a substance, which in its own right is considered to be a medicinal substance

Accessories to medical devices are classified separately to the device, excluding accessories to active implantable devices. See guidance on how to establish which classification your product falls under.

All active implantable medical devices and their accessories fall under the highest risk category (Class III).

In vitro diagnostic medical devices (IVDs)

In vitro diagnostic medical devices are categorised differently into 4 main groups, which are devices:

• considered as general IVD medical devices
• within the classifications stated in Part IV of the UK MDR 2002, Annex II List A (as modified by Part III of Schedule 2A to the UK MDR 2002)
• within the classifications stated in Part IV of the UK MDR 2002, Annex II List B (as modified by Part III of Schedule 2A to the UK MDR 2002)
• for ‘self-test’ intended to be used by a person at home

Conformity assessment and UKCA marking

Once you have established how your device should be classified or categorised, you will need to follow the conformity assessment route to show that it has met the requirements in the UK MDR 2002. For more information on marking of medical devices, see our guidance on how medical devices are regulated.

Assessment route for general medical devices and active implantable devices

If you have decided that your medical device falls into Class II, IIb or III, or is a Class I device that is sterile or has a measurement function, you need to contact a UK Approved Body that can carry out a conformity assessment for the specific classification.

A UK Approved Body ensures manufacturers comply with the regulations including reviewing clinical and scientific data, manufacturing processes and the quality management system. If they comply the UK Approved body will issue a UKCA certificate, which manufacturers can place on their device to show that it has passed the conformity assessment. See more information on the role of a UK Approved Body and the list of UK Approved Bodies in Great Britain.

The conformity assessment route is different for devices being placed on the market in Northern Ireland. For more information please see our guidance.

Class I medical devices do not need to go through a conformity assessment with a UK Approved Body if they are non-sterile and don’t have a measuring function as they are generally low risk.

You must register all medical devices on the Great Britain market with the MHRA.

Assessment route for IVDs

You must register all IVDs with the MHRA. If your product is listed in Part IV of the UK MDR 2002, Annex II (as modified by Part III of Schedule 2A to the UK MDR 2002) or is a self-test device, you will need to contact a UK Approved Body.

UK Approved Bodies will need to release in vitro products with the highest risk on a batch-by-batch basis. They will need to ensure that the product meets the relevant requirements before certifying it. You can then place the UKCA mark on your product to demonstrate compliance and it will be ready to place in the Great Britain market.

See the different routes to conformity for IVDs in our guidance.

The conformity route is different for devices manufactured in healthcare establishments, see the guidance on in-house manufacturer of devices for more information.

The conformity assessment route is different for devices being placed on the market in Northern Ireland. For more information please see our guidance.

Clinical data and clinical investigations

Manufacturers must hold clinical data to support claims made for all types of medical devices. This may be based on clinical investigations and in some cases published literature, where you can demonstrate equivalence. See more information on clinical evaluations.

You must inform the MHRA if you are planning to conduct a clinical investigation at least 60 days before starting your investigation. This does not currently apply to IVDs, although you must notify the MHRA about IVDs for performance evaluations.

Post-market monitoring and surveillance

Once a medical device has been placed on the Great Britain market, the manufacturer is responsible for monitoring the product and reporting serious adverse incidents to the MHRA. See guidance on reporting adverse incidents for information on how to do this. This ensures the device is acceptably safe to use for as long as it is in use.

See how to report a non-compliant medical device if you notice any issue with a medical device placed on the Great Britain market.