Guidance and regulation

What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 8 February 2024

How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 11 January 2024

The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 29 February 2024

• The Innovative Devices Access Pathway (IDAP) - pilot phase

  The pilot phase of the development of a new pathway supporting innovative…

• IDAP pilot application guidance (now closed)

  The Innovative Devices Access Pathway (IDAP) pilot is designed to…

• Patient and public involvement and engagement in IDAP

  We offered the following opportunities for patients and the public to…

How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 10 April 2024

Information on MHRA's enforcement duties and how to report a non-compliant medical device.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 1 July 2023

How to conform with the legal requirements for placing medical devices on the market.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

Information on when software applications are considered to be a medical device and how they are regulated.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 1 July 2023

UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 25 March 2024

What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 11 July 2023

Information about the EU Regulations and their implementation in Northern Ireland

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 25 March 2024

Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 17 July 2023

Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 26 March 2021

Information about suspected side effects of e-cigarettes and how to report side effects.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 17 April 2024

Guidance on what approved bodies are, what they do and how you can become one.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 1 July 2023

Advice on writing clear notices and maximising replies to your FSNs.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 1 January 2021

Information and guidance on a range of medical devices for users and patients.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 21 November 2023

How to comply with the regulatory requirements for manufacturing custom-made medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 1 July 2023

Information for clinicians and patients.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 28 April 2023