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Learn more about technical standards, why they are important and how to follow them.

This is required guidance

It is legally required and it is an essential activity.

This Guide covers:

  • Great Britain (England, Scotland, Wales)

From:

Developers - Getting a UKCA mark: regulations for placing medical devices on the market

To place medical devices on the health and social care market in England, Wales and Scotland you need to meet certain regulations. Learn here which regulations apply to your device and how to meet them.

If you do not know if your technology is a medical device, read the guidance from GOV.UK on borderline products.

The UKCA mark and why you need it

Before you place medical devices on the market in England, Wales and Scotland you need to get a UK Conformity Assessed (UKCA) mark or a relevant CE mark. This is required by law.

The mark shows your device meets the requirements of the UK Medical Device Regulations 2002 (UK MDR 2002).

You can get a UKCA mark through assessment carried out by a conformity assessment body. The type of assessment will depend on the classification of your device.

If you do not follow these requirements the MHRA may prosecute you. This could result in 6 months in prison or an unlimited fine.

Here’s how to get a UKCA mark: 

Step 1: Find out which requirements are relevant to your device

To get a UKCA mark you must first meet the requirements relevant to your device. The UK MDR recognises 3 main types of medical devices. All 3 have separate requirements listed in separate parts. These parts list the essential requirements your device must meet to ensure patient safety. 

The 3 main types of medical devices are:

Step 2: Prove you have met the requirements

You can prove your medical device meets relevant requirements by getting it assessed for conformity. The type of conformity assessment depends on the risk classification of your device.

Medical device risk classification

The law classifies a device based on the level of risk associated with it. The higher the risk to the patient, the stricter the controls on its use will be.

Risk classification of medical devices is the process of reviewing and implementing the classification rules of the UK MDR 2002 against the intended purpose statement and determining the appropriate risk classification of the medical device.

The risk classification is applied to the device for all labelling and registration activities. It influences processes and evidence requirements over the device’s lifecycle. 

The classification type will dictate if your device needs to be:

  • assessed by an approved or notified body
  • self-assessed as meeting the legislative requirements

Risk classification is one component in determining the level and type of evidence that needs to be generated. For example, certain methods that prove conformity to the essential requirements are only available to certain risk classes of medical devices.

Misclassification of device risk may lead to compliance actions against your organisation. This can delay or stop you placing the medical device on the market, which may cost money and cause reputational damage. 

Medical device classification for general and active implantable devices

These are the different device classifications for general medical devices and active implantable devices:

How your medical device is classified depends on many factors, including:

  • the intended purpose
  • where on the body the technology is used
  • how the information supplied by the device will be used

Medical device classification for in vitro diagnostic medical devices

In vitro diagnostic medical devices have a different risk-classification system to general and active implantable medical devices. 

In vitro diagnostic medical devices are categorised into 4 main groups. You can view this classification system on GOV.UK

How to determine the classification of medical devices

Review the classification annex of the relevant legislation under the UK MDR 2002 to:

  • locate the rules
  • determine which rules are applicable and review them against the intended purpose statement, and relevant definitions

Follow the implementation rules within the classification annex.

See information from GOV.UK on when software applications are considered to be a medical device and how they are regulated.

When determining the risk classification of medical devices, also think about reviewing definitions in guidance from:

The conformity assessment

When you know the class of your device, you may need to get it assessed by an approved body. There are several approved bodies in the UK, and you are free to choose a suitable one. Make sure they are qualified and experienced in certifying devices of your class.

Use the conformity assessment routes guide on GOV.UK to explore the routes to conformity assessment for your device. 

For the purposes of this guide, read:

  • ‘CE marking’ as ‘UKCA marking ’
  • ‘Competent Authority’ as ‘MHRA’
  • ‘Notified body’ as ‘approved body’

Search the register of UK conformity assessment bodies.

Read the BSI guide to notified bodies for more information on conformity assessments. The BSI is an approved body in the UK. 

How to pass your conformity assessment

  • Identify which regulations apply to the intended use of your device (step 1).
  • Identify the requirements you must follow to gain your UKCA mark (step 2).
  • Put together documents that reference each requirement and how you have met it. You can create most of this documentation from your Quality Management System (QMS) processes. If you have not set up your QMS, do it before or in parallel with the device documentation. This makes sure you use systematic approaches.
  • Show evidence of:
    • Processes
    • Risk management systems
    • Device design
    • Device development
    • Clinical evaluation

You must follow these regulations before placing your device on the market. If your device changes after it has been placed on the market, reassess if you are still meeting the requirements. 

After you have passed your conformity assessment 

Once you have passed your conformity assessment, you will receive a certificate. Then, you can place the UKCA mark on your device. You will also need to place the identification number of the approved body on your device and register yourself and your device with the MHRA.

This information is not intended to replace formal statutory guidance regarding legal requirements. For an authoritative view of what regulations require beyond this digest, please see the relevant gov.uk web pages pertaining to the MHRA.

Learn more about technical standards, why they are important and how to follow them.

This is required guidance

It is legally required and it is an essential activity.

This Guide covers:

  • Great Britain (England, Scotland, Wales)

From:

Get more support

To discover how the MHRA can assist you and for contact details, visit our 'Get Support' page.

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