What regulatory approvals do medical or diagnostic devices require?

This page will help you understand questions such as:

• Is my innovation a medical device?
• What classification is my medical device?
• What regulatory approvals do medical or diagnostic devices require?

Is my innovation a medical device?

Medical devices fall into one or more of the following categories:

General medical devices

For example, ECG monitors or dialysis machines, including any software used to drive them.

Active Implantable Medical Devices (AIMDs)

Powered implants or partial implants left in the body. This could include implantable cardiac pacemakers or cochlear implants.

In Vitro Diagnostic Medical Devices (IVDs)

All equipment / systems for use in vitro to examine specimens. For example, pregnancy test kits and hepatitis B test kits.

Digital software

For example, standalone software, decision tools and applications.

What risk classification is my medical device?

Medical devices can be classified into three main risk tiers:

Class I

Low risk, non-invasive devices, such as medicine spoons or standard adhesive bandages, that are used day-to-day.

Class II

Mid-tier risk devices:

• Class IIa: Low to medium risk medical devices that are placed within the body for between 60 minutes to 30 days. For example, short-term corrective contact lenses or standard hearing aids.
• Class IIb: Medium to high-risk medical devices that are placed within the body for 30 days or more. For example, ventilators or sleep apnoea monitors.

Class III

High risk devices. For example, pacemakers or contraceptive intrauterine devices. This includes Active Implantable Medical Devices.

What regulatory approvals do medical or diagnostic devices require?

Medical or diagnostic devices typically require:

Compliance with UK Medical Device Regulations 2002 and UKCA marking

The requirements set out by the UK Medical Device Regulations 2002 are legal requirements that apply to all medical devices to ensure they are safe and effective for patients and staff.

Medical devices must have an intended purpose statement. This defines where the medical device fits in a pathway, whether it is classed as a medical device (and if so, what risk class the medical device fits within), and the evidence that is required to demonstrate the need for the device within the system.

Innovators must show how the medical device fulfils the requirements of the UK Medical Device Regulations 2002. This can be completed through a live working document that contains all evidence of the medical device conforming to the regulations to date.

Medical device classification determines the level of assessment required to fulfil UK Medical Device Regulations 2002 requirements. Class I medical devices can self-certify, whereas Class II and III medical devices must be assessed by an approved body. Upon successful assessment, a UKCA mark can be assigned to the medical device. CE marked devices are accepted in the UK until 30^th June 2030, depending on the type and classification of the medical device.

Medicines and Healthcare products Regulatory Agency (MHRA) registration

Medical devices must be registered with the MHRA before being marketed in the UK. To register, the following information is required:

• Manufacturer details
  • Legal entity name and address as it appears on the medical device itself
  • Company type
  • Administrative contact
  • Letter of designation for UK Responsible Persons if applicable
• Device details
  • Applicable legislation
  • Medical device class
  • Globel Medical Devices Nomenclature (GMDN)® Code and Term to describe the medical device
  • UDI-DI if applicable
  • Medical device name
  • Model or version detail
  • Catalogue or reference number
  • UK Approved Body (or EU Notified Body) if applicable
  • Attributes (for example, sterility or whether the medical device is MRI compatible)
• Conformity assessment certificates or self-certification conformity declarations

Alignment with NICE guidance

Medical devices must reflect best practice and evidence-based care as depicted within guidance from NICE. In particular, NICE’s HealthTech guidance is relevant for early development innovations. Guidance around treating and managing different conditions or diseases is also available.

Clinical safety standards

The NHS requires DCB0129 (clinical risk management for manufacturers) and DCB0160 (clinical risk management for health organisations) to identify and control risks of harm. DCB0129 requires a clinical safety officer, a clinical risk management file, a hazard log, a clinical safety case report, and post-market clinical safety processes. DCB0160 requires the adopter to review the manufacturer’s DCB0129 documentation, conduct a local clinical risk assessment, a local hazard log, a local clinical safety case report, and ongoing governance once live. This assesses whether the medical device is safe in the local environment that it is going to be adopted within.

Data protection compliance

Medical devices must comply with data protection laws in the UK. For more information on data protection compliance, check out the guidance here.

Net zero requirements

Innovations must align with delivering a net zero NHS by 2040. As well as this, innovations must adhere to carbon reporting expectations. A full Carbon Reduction Plan is required for procurements of over £5 million per annum including VAT, or a Net Zero Commitment for procurements lower than £5 million per annum including VAT.

Overall, correctly identifying whether your innovation is a medical device and understanding its classification is essential for determining the regulatory pathway it must follow. Different device types and risk classes are subject to varying levels of scrutiny, conformity assessment, and approval requirements. Innovators must ensure compliance with UK regulations, including MHRA registration, UKCA marking, and relevant clinical safety, evidence, and data protection standards.