Medical devices given exceptional use authorisations during the COVID-19 pandemic
Added HeartWave Inc (Medtronic Ltd) HVAD Controller to the New medical devices given exceptional use authorisations list.
Added link to application form to 'apply for Small and Medium Company status'.
Advice for consumers
E-cigarette analysis print updated.
- Alerts, recalls and safety information: drugs and medical devices
Supplying authorised medicines to Northern Ireland
Updates to the Supply of authorised medicines to Northern Ireland guidance.
Notify the MHRA about a clinical investigation for a medical device
Updated information on how to submit the SAE reporting form.
MHRA ethnicity pay gap report
Uploaded the ethnicity pay gap report for 2021-2022
Exceptional use of non-UKCA marked medical devices
Updated file 'Humanitarian use of device - application form'
Medical devices: UK approved bodies
The UL Internationa UK Ltd Scope document has been updated.
Register medical devices to place on the market
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
Updated changes to the Incident reporting system
Borderline products: how to tell if your product is a medical device and which risk class applies
New section added 'Risk classification of medical devices'
Equity in medical devices: independent review call for evidence
Added contact email in case of any queries.
How tests and testing kits for coronavirus (COVID-19) work
Edited according to UK government style guide
- MHRA appoints first new UK Approved Body to certify medical devices since Brexit
Medical devices: software applications (apps)
Added - 'Appendix 4 – Field Safety Warnings and End-of-Life notification'
Export medical devices
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
Consultation response published
- New safety warnings on risk of insulin leakage from Roche Accu-Chek Insight Insulin pumps
- Changes to Human Medicine Regulations to support the rollout of vaccines: one-year review
Regulatory approval of Xevudy (sotrovimab)
Uploaded the Public Assessment Report for Xevudy
- Chapter 5 - Presentation Guidance Northern Ireland
- Chapter 5 - Presentation Guidance - Great Britain
- Chapter 3 - Emissions Guidance - Great Britain
- Chapter 7 - Annual Reporting Guidance - Great Britain
- Chapter 8 - Labelling Guidance - Great Britain
- Chapter 9 - General Advice on Due Diligence - Great Britain
- Chapter 10 - General Advice on Vigilance - Great Britain
- Chapter 1.1 - Submission Type Guidance Northern Ireland
- Chapter 1 - Submitting Notifications EUCEG Guidance - Northern Ireland
- Chapter 2 - Product Type Guidance Northern Ireland
- Chapter 3 - Emissions Guidance Northern Ireland
- Guidance on the submission and content of notifications for Great Britain
- Chapter 6 - Ingredient Guidance - Great Britain
- Chapter 4 - Nicotine Dose Guidance - Great Britain
- Chapter 4 - Nicotine Dose Guidance Northern Ireland
- Chapter 6 - Ingredient Guidance Northern Ireland
- Chapter 7 - Annual Reporting Guidance Northern Ireland
- Chapter 8 - Labelling Guidance Northern Ireland
- Chapter 9 - General advice on due diligence Northern Ireland
- Chapter 10 - General Advice on Vigilance - Northern Ireland
- New national cervical screening campaign launches – as nearly 1 in 3 don’t take up screening offer
Review of temporary provisions in the Human Medicines Regulations 2012 to support influenza and COVID-19 vaccination campaigns
Consultation response published.
Regulating medical devices in the UK
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)
Software specifically intended to read lateral flow tests (test readers), added.
Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
Information added regarding software products that read lateral flow tests
Assistive technology: definitions, examples and safe use
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
- Good Machine Learning Practice for Medical Device Development: Guiding Principles
- Infusion pumps: T34 syringe drivers