Latest guidance from MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK.
Click the "Read more" link to see the latest guidance from MHRA published on www.gov.uk
Below is a summary of recent updates to the guidance published on www.gov.uk
January 2024
- Page updated: Register medical devices to place on the market - Added a reminder of the legislation requirements for custom-made devices.
- Page updated: Implementation of the Future Regulations - guidance has been updated with a Roadmap towards the future regulatory framework for medical devices.
- First publication: Roadmap towards the future regulatory framework for medical devices.
December 2023
- Page update: Notify the MHRA about a clinical investigation for a medical device - Added a PDF on electrical guidance for clinical investigations.
- Page update: Notify the MHRA about a clinical investigation for a medical device - Added ‘Tabular Summary input (template) for non marked IVD devices’
- Page update: The Innovative Devices Access Pathway (IDAP) program - The IDAP Pilot is now closed for applications.
- Page update: Register medical devices to place on the market - Clarification provided concerning fees and actions required to change legislation of a registered device.
September 2023
- First publication: The Innovative Devices Access Pathway (IDAP) program.
June 2023
- Publication of the Medical Devices (Amendment) (Great Britain) Regulations 2023 - regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
- Page update: Notify the MHRA about a clinical investigation for a medical device - Updated information on ‘MHRA / HRA Coordinated pathway’.
- Page update: Register medical devices to place on the market - Reference guides and the videos ‘update devices and update products individually’ and ‘review and renew registration’ have been updated.
May 2023
- Page update: Register medical devices to place on the market - Reference guides updated and new video tutorials added.
- Page update: MHRA fees - Amendment fees added to the ‘Current MHRA fees’ webpage.
- Page update: Medical devices: guidance for manufacturers on vigilance - Added link to ‘Guidance: Reporting adverse incidents involving Software as a Medical Device under the vigilance system’.
- Page update: Export medical devices - Updated video tutorial for ‘How to order and reorder Certificates of Free Sale’.
- Page update: Medical devices: software applications (apps) - Updated file ‘Medical device stand-alone software including apps’ to include information on the implementation of new regulations, updates to various links including MORE and new software vigilance guidance.
- Page update: Register medical devices to place on the market - Changes to DORS instructions for Scenarios 1 to 4 in the Guidance on registration of medical devices with an expired or expiring CE Certificate.
- Page update: Notify the MHRA about a clinical investigation for a medical device - Added Validation Checklist text and document.
- The following pages were updated to have a paragraph added which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.
- Virtual manufacturing of medical devices
- Assistive technology: definitions, examples and safe use
- DEHP phthalates in medical devices
- How tests and testing kits for coronavirus (COVID-19) work
- Guidance on Class I medical devices
- Medical devices: legal requirements for specific medical products
- Medical devices: off-label use
- Medical devices regulations: compliance and enforcement
- Approved bodies for medical devices
- Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
April 2023
- Page update: Medical devices: guidance for manufacturers on vigilance - Information and links to the MORE Submissions guidance and MORE production API guidance have been added.
- Page update: Register medical devices to place on the market - Added Guidance on registration of medical devices with an expired or expiring CE certificate that is valid under EU Medical Devices Regulations.
- Page update: Symptoms sometimes referred to as Breast Implant Illness - Information about a project to better understand how patients and the public perceive the risks has been included, as well as additional information about clinical stakeholders.
- Page update: Regulating medical devices in the UK - This guidance was updated primarily to reflect an intended extension to acceptance of CE marked medical devices on the Great Britain market beyond 30 June 2023. This guidance has been updated with changes to ‘Summary of key requirements for placing a device on the Great Britain market’, ‘Registrations in Great Britain’, ‘UKCA marking’, ‘CE marking and Notified Bodies’, ‘Labelling requirements’ and ‘Regulation of medical devices in Northern Ireland’ Reference Guides.
- Page update: MHRA fees - Updated MHRA fees for 2023 – 2024. Added links: The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 & The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023.
March 2023
- Page update: Export medical devices - Updated ‘Certificates of Free Sale for Medical Devices’ PDF.
- Page update: Register medical devices to place on the market - Updates to the Review Registration, Making Changes to your registration and Public Register of Manufacturers sections. Updated Account Management and Device Registration Reference Guides.
- Page update: MHRA fees - Added link to application form to ‘apply for Small and Medium Company status’.
January 2023
- Page update: Notify the MHRA about a clinical investigation for a medical device - Updated information on how to submit the SAE reporting form.
December 2022
- Page update: Medical devices: UK approved bodies - The UL International UK Ltd (IVDR) Scope document updated.
- Page update: Medical devices: guidance for manufacturers on vigilance - Updated changes to the Incident reporting system.
- Page update: 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)’.
November 2022
- Page update: Notify the MHRA about a clinical investigation for a medical device - Clinical investigation numbers for 2021 added.
- Guidance update: Borderline products: how to tell if your product is a medical device - New section added ‘Risk classification of medical devices’.
- Page update: Register medical devices to place on the market - Link included to updated guidance on ‘Borderline products: how to tell if your product is a medical device’.
October 2022
- News item: MHRA appoints first new UK Approved Body to certify medical devices since Brexit - DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies.
- Public consultation: Equity in medical devices: independent review call for evidence - We are seeking your views on the design, development, evaluation and use of medical devices.
- Guidance update: Medical devices: guidance for manufacturers on vigilance - Detailing changes to the Incident reporting system in the section ‘Changes to the Incident reporting system’.
- Page update: Medical devices: guidance for manufacturers on vigilance - Recording added for webinar ‘Changes to Submitting Adverse Incidents to Medical Devices to the MHRA’.
September 2022
- Guidance update: Notify the MHRA about a clinical investigation for a medical device - Added section ‘Quarterly Summary Reports’.
- Page update: MHRA fees – updated fees payable to the MHRA for 2022 to 2023
- Guidance update: Medical devices: software applications (apps) – Added Appendix 4; Field Safety Warnings and End-of-Life notification
- Page update: Medical devices: UK approved bodies - Added DEKRA Certification UK Ltd (8505.
July 2022
- Guidance update: Register medical devices to place on the market - New section added ‘Coronavirus Test Device Approval (CTDA) and Registering with MHRA’
- Guidance update: Export medical devices - Additonal paragraph added to ‘Certificates of free sale’ section.
June 2022
- Page update: Consultation on the future regulation of medical devices in the United Kingdom - Consultation response published
May 2022
- Page update: Medical devices: UK approved bodies – Updated scope; SGS United Kingdom Limited (Medical Devices Scope) and UL International (UK) Ltd (In-vitro Diagnostics Medical Devices Scope)
- Guidance update: Notify the MHRA about a clinical investigation for a medical device - Section added for “Study deviations” and related XLS.
March 2022
- Page update: Medical devices: UK approved bodies - Updates made to contact details.
January 2022
- Guidance update: Regulating medical devices in the UK - Updated to reflect changes to medical device regulatory requirements that took effect on 1 January 2022 – suspension of registrations of Authorised Representatives and of non-UK manufacturers without a UK Responsible Person.
- Guidance update: Register medical devices to place on the market - Updated to reflect changes to medical device registration requirements that took effect on 1 January 2022 – non-UK manufacturers require a UK Responsible Person for registering devices placed on the Great Britain market. Authorised Representatives, including those based in Northern Ireland, can no longer register devices on a non-UK manufacturer’s behalf for the Great Britain market.
- Guidance update: Notify the MHRA about a clinical investigation for a medical device - MHRA and HRA coordinated assessment pathway added to guidance.
November 2021
- Notify the MHRA about a clinical investigation for a medical device Information added for notifications for clinical investigation or study amendments between 17 December 2021 and 10 January 2022.
October 2021
- Consultation on the future regulation of medical devices in the United Kingdom Details of Webinar recordings added.
- Register medical devices to place on the market Section added - ‘Review registration’.
- Export medical devices Updated Certificates of Free Sale Reference Guide.
- Borderlines with medical devices and other products in Great Britain Updates made.
September 2021
- MHRA launches public consultation on future of medical device regulation People are being encouraged to contribute their views on changes to how medical devices will be regulated across the UK.
- Consultation on the future regulation of medical devices in the United Kingdom Seeking your views on how medical devices will be regulated across the United Kingdom (UK) in the future.
August 2021
- Export medical devices The reference guides and attributes list updated and new and updated videos created.
- Register medical devices to place on the market Updated links to video tutorials and information.
July 2021
- Medical devices: UK approved bodies Attachments updated
- News story: MHRA’s new Chief Safety Officer, Dr Alison Cave, starts vital vigilance work today
- Medical devices: software applications (apps) Changes to qualification of IVD software and intended purpose.
June 2021
- Notify the MHRA about a clinical investigation for a medical device Added a note about clinical trial applications, where the clinical performance of the IVD is yet to be demonstrated.
- How tests and testing kits for coronavirus (COVID-19) work Added a new Target Product Profile: In Vitro Diagnostic (IVD) self-tests for the detection of SARS-CoV-2 in people without symptoms.
May 2021
- Register medical devices to place on the market Updated the Manufacturer and Device and Product and Importer Attributes.
- Notify the MHRA about a clinical investigation for a medical device Updated due to the EU Medical Device Regulation (MDR) coming into effect in Northern Ireland from 26 May. Provides technical details for clinical investigations in Northern Ireland.
- Medical devices: EU regulations for MDR and IVDR (Northern Ireland) Update to information under section ‘Importer requirements’.
- How tests and testing kits for coronavirus (COVID-19) work Added new section – Common terms related to COVID-19 testing
April 2021
- Register medical devices to place on the market Updated Account Management Reference Guide and Device Registration Reference Guide.
- Export medical devices Updated Certificate of Free Sale Reference Guide.
March 2021
- How tests and testing kits for coronavirus (COVID-19) work Added new guidance for testing kit providers.
- Notify the MHRA about a clinical investigation for a medical device Added information on the number of valid clinical investigation applications that have been reviewed by year.
- The use and regulation of pulse oximeters (information for healthcare professionals) Published information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices.
- Register medical devices to place on the market Added a new video – Registering an IVD for Performance Evaluation.
- Medical devices: legal requirements for specific medical products Updated CE, CE UKNI and UKCA marking guidance for prosthetic, orthotic and ophthalmic devices in line with the end of the Brexit transition period.
February 2021
- How tests and testing kits for coronavirus (COVID-19) work The document for industry and manufacturers has been updated to include the new UKCA, CE and CE UKNI markings.
- Regulatory status of equipment being used to help prevent coronavirus (COVID-19) Updated references to CE, CE UKNI and UKCA markings in line with the end of the Brexit transition period.
- Medical devices: information for users and patients Adding in guidance around baby breathing / movement monitors.
- Guidance on applying human factors to medical devices Updated guidance to reflect the end of the transition period. The updates primarily apply to Great Britain, changes in references to legislation and the introduction of the new UKCA mark.
- Assistive technology: definitions, examples and safe use Updated the guidance following the end of the transition period. This includes a new section on the regulations in Northern Ireland.
- In vitro diagnostic point-of-care test devices Published a new version of the guidance following the end of the transition period.
- Virtual manufacturing of medical devices Published a new version of the guidance following the end of the transition period.
January 2021
- Medicines and Medical Devices Bill: overarching documents Further documents added.
- DEHP phthalates in medical devices Updated to reflect changes in regulations following the Brexit transition.
- Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID-19) outbreak Uploaded a new PDF to reflect changes to regulations following Brexit transition.
- Regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with coronavirus (COVID-19) Updated to reflect changes to regulations following Brexit transition.
- Notify the MHRA about a clinical investigation for a medical device Added revised information about Health Research Authority (HRA) and Health and Care Research Wales (HCRW) Approval. Also added new information about the Coordinated assessment pathway pilot.
- Guidance for retailers: supplying medical devices to Northern Ireland First published.
- Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak Updated to add information about CE, CE UKNI and UKCA markings due to the end of the Brexit transition period.
- Borderline products: how to tell if your product is a medical device First published.
- Medical devices: UK approved bodies Changed designations for BSI Assurance UK Ltd under the MDR and IVDR and updated contact information.
- Notify the MHRA about a clinical investigation for a medical device This page has been updated due to the end of the transition period.
- Medical devices: EU regulations for MDR and IVDR (Northern Ireland) This page has been updated due to the end of the Brexit transition period.
- In vitro diagnostic medical devices: guidance on legislation This page has been updated due to the end of the Brexit transition period.
- In-house manufacture of medical devices in Great Britain Updated as a result of the end of the Brexit transition period.
- Export medical devices Updated due to the end of the Brexit transition period.
- Medical devices: how to comply with the legal requirements in Great Britain This guidance has been updated as a result of the end of the Brexit transition period.
- Medical devices: guidance for manufacturers on vigilance This page has been updated due to the end of the Brexit transition period.
- Custom-made medical devices in Great Britain This has been updated due to the end of the Brexit transition period.
- Medical devices: conformity assessment and the UKCA mark First published.
- Exceptional use of non-UKCA marked medical devices First published.
- Approved bodies for medical devices First published.
- Regulating medical devices in the UK First published.
- Register medical devices to place on the market First published.
- Medical devices: UK approved bodies First published.
- MHRA guidance on the health institution exemption (HIE) – IVDR and MDR (Northern Ireland) First published.
- Register as a manufacturer to sell medical devices Added link to guidance on registration requirements from 1 January 2021.