Medical devices regulation and safety

Latest documents

• From: Medicines and Healthcare products Regulatory Agency, Department of Health and Social Care, Commission on Human Medicines, British Pharmacopoeia Commission, Driver and Vehicle Licensing Agency, and Closed organisation: Public Health England

Subscriptions

• Get emails for this topic

• Medical devices given exceptional use authorisations during the COVID-19 pandemic
  • 14 March 2023

  Added HeartWave Inc (Medtronic Ltd) HVAD Controller to the New medical devices given exceptional use authorisations list.

• MHRA fees
  • 8 March 2023

  Added link to application form to 'apply for Small and Medium Company status'.

• Advice for consumers
  • 9 February 2023

  E-cigarette analysis print updated.

• Alerts, recalls and safety information: drugs and medical devices
  • 7 February 2023

• Supplying authorised medicines to Northern Ireland
  • 23 January 2023

  Updates to the Supply of authorised medicines to Northern Ireland guidance.

• Notify the MHRA about a clinical investigation for a medical device
  • 20 January 2023

  Updated information on how to submit the SAE reporting form.

• MHRA ethnicity pay gap report
  • 6 January 2023

  Uploaded the ethnicity pay gap report for 2021-2022

• Exceptional use of non-UKCA marked medical devices
  • 30 December 2022

  Updated file 'Humanitarian use of device - application form'

• Medical devices: UK approved bodies
  • 20 December 2022

  The UL Internationa UK Ltd Scope document has been updated.

• Register medical devices to place on the market
  • 6 December 2022

  Text edited in the introduction and in the section 'Apply to register on the Device Online Registration System (DORS)'.

• Medical devices: guidance for manufacturers on vigilance
  • 5 December 2022

  Updated changes to the Incident reporting system

• Borderline products: how to tell if your product is a medical device and which risk class applies
  • 16 November 2022

  New section added 'Risk classification of medical devices'

• Equity in medical devices: independent review call for evidence
  • 24 October 2022

  Added contact email in case of any queries.

• How tests and testing kits for coronavirus (COVID-19) work
  • 7 October 2022

  Edited according to UK government style guide

• MHRA appoints first new UK Approved Body to certify medical devices since Brexit
  • 29 September 2022

• Medical devices: software applications (apps)
  • 8 September 2022

  Added - 'Appendix 4 – Field Safety Warnings and End-of-Life notification'

• Export medical devices
  • 7 July 2022

  Extra paragraph added to 'Certificates of free sale' section: 'In issuing a CFS, the MHRA does not assess or verify that the product complies with relevant export requirements and restrictions. It is the applicant’s responsibility to ensure compliance with these requirements and restrictions. Please see The Russia Sanctions Regulations 2022 and Consolidated list of strategic military and dual-use items that require export authorisation.'

• Consultation on the future regulation of medical devices in the United Kingdom
  • 26 June 2022

  Consultation response published

• New safety warnings on risk of insulin leakage from Roche Accu-Chek Insight Insulin pumps
  • 26 May 2022

• Changes to Human Medicine Regulations to support the rollout of vaccines: one-year review
  • 5 April 2022

• Regulatory approval of Xevudy (sotrovimab)
  • 28 March 2022

  Uploaded the Public Assessment Report for Xevudy

• Chapter 5 - Presentation Guidance Northern Ireland
  • 28 March 2022

• Chapter 5 - Presentation Guidance - Great Britain
  • 23 March 2022

• Chapter 3 - Emissions Guidance - Great Britain
  • 23 March 2022

• Chapter 7 - Annual Reporting Guidance - Great Britain
  • 23 March 2022

• Chapter 8 - Labelling Guidance - Great Britain
  • 23 March 2022

• Chapter 9 - General Advice on Due Diligence - Great Britain
  • 23 March 2022

• Chapter 10 - General Advice on Vigilance - Great Britain
  • 23 March 2022

• Chapter 1.1 - Submission Type Guidance Northern Ireland
  • 23 March 2022

• Chapter 1 - Submitting Notifications EUCEG Guidance - Northern Ireland
  • 23 March 2022

• Chapter 2 - Product Type Guidance Northern Ireland
  • 23 March 2022

• Chapter 3 - Emissions Guidance Northern Ireland
  • 23 March 2022

• Guidance on the submission and content of notifications for Great Britain
  • 23 March 2022

• Chapter 6 - Ingredient Guidance - Great Britain
  • 23 March 2022

• Chapter 4 - Nicotine Dose Guidance - Great Britain
  • 23 March 2022

• Chapter 4 - Nicotine Dose Guidance Northern Ireland
  • 23 March 2022

• Chapter 6 - Ingredient Guidance Northern Ireland
  • 23 March 2022

• Chapter 7 - Annual Reporting Guidance Northern Ireland
  • 23 March 2022

• Chapter 8 - Labelling Guidance Northern Ireland
  • 23 March 2022

• Chapter 9 - General advice on due diligence Northern Ireland
  • 23 March 2022

• Chapter 10 - General Advice on Vigilance - Northern Ireland
  • 23 March 2022

• New national cervical screening campaign launches – as nearly 1 in 3 don’t take up screening offer
  • 14 February 2022

• Review of temporary provisions in the Human Medicines Regulations 2012 to support influenza and COVID-19 vaccination campaigns
  • 25 January 2022

  Consultation response published.

• Regulating medical devices in the UK
  • 1 January 2022

  This guidance was updated to reflect changes to medical device regulatory requirements that will take effect on 1 January 2022.

• Regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with coronavirus (COVID-19)
  • 17 December 2021

  Software specifically intended to read lateral flow tests (test readers), added.

• Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
  • 17 December 2021

  Information added regarding software products that read lateral flow tests

• Assistive technology: definitions, examples and safe use
  • 28 October 2021

  Updated information on page Assistive technology: definition and safe use

• UK, USA and Canadian regulators identify 10 guiding principles to be addressed when medical devices use AI or machine learning software
  • 27 October 2021

• Good Machine Learning Practice for Medical Device Development: Guiding Principles
  • 27 October 2021

• Infusion pumps: T34 syringe drivers
  • 19 October 2021