Medical devices: how to comply with the legal requirements in Great Britain
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Overview
This guidance outlines the steps you need to follow before your product can be placed on the Great Britain market with a UKCA mark.
This guidance is specific to the provisions in Great Britain (England, Wales and Scotland). For information on how to comply with the legal requirements in Northern Ireland, please see our guidance on Northern Ireland.
Definition of a medical device
You need to decide if your product is a medical device before you go through the compliance process.
According to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), a medical device is described as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which is 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, or
- control of conception
A medical device does not achieve its main intended action by pharmacological, immunological or metabolic means although it can be assisted by these.
A medical device includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.
If you are manufacturing a medical device you must follow the specific Part for your type of product as it sets out the essential requirements the product must meet in the interest of patient safety. See more information on what a medical device is in the UK MDR 2002.
See the guidance on borderline products if you are unsure whether your product is a medicine or a medical device or if it overlaps.
Medical device types and their associated Part
The 3 main types of medical devices and their associated Part in the UK MDR 2002 are:
- general medical devices: Part II of the UK MDR 2002
- active implantable medical devices: Part III of the UK MDR 2002
- in vitro diagnostic medical devices (IVDs): Part IV of the UK MDR 2002
You must meet the requirements in the relevant Part before your device can be placed in the market.
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 are risk classified separately to general medical devices. Specific requirements for these devices can be found in Part III of the UK MDR 2002.
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.
Active implantable devices are considered a separate risk class to general medical devices. Specific requirements for these devices can be found in Part III of the UK MDR 2002.
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.
Last updated 31 December 2020 + show all updates
-
This guidance has been updated as a result of the end of the Brexit transition period.
-
Added a link to new guidance on medical devices regulation in a no deal scenario.
-
First published.