Patient Involvement Strategy: an assessment of progress
Page summary:
Progress made in delivering the Patient Involvement Strategy, October 2021 – January 2025.
Change made:
First published.
Time updated:
11:59am, 13 January 2025
MHRA Real-World Evidence Scientific Dialogue Programme
Page summary:
A programme to help facilitate robust decision-making across the entire lifecycle of products, benefitting both regulatory and Health Technology Assessment (HTA) evaluations relevant to the UK.
Change made:
First published.
Time updated:
12:19pm, 13 January 2025
Medical devices given exceptional use authorisations during the COVID-19 pandemic
Page summary:
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Change made:
Added ‘Greiner Bio-One GmbH – DEU/012/2024/003’ to List of medical devices given exceptional use authorisations
Time updated:
9:24am, 14 January 2025
Medical devices: periodic safety update report (PSUR)
Page summary:
Information and recommendations on the presentation and review of a PSUR
Change made:
First published.
Time updated:
10:00am, 15 January 2025
Medical devices: examples of reportable incidents
Page summary:
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
Change made:
First published.
Time updated:
10:00am, 15 January 2025
Medical devices: post-market surveillance
Page summary:
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
Change made:
Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 15 January 2025
Regulation of devices in Northern Ireland
Page summary:
Information about the EU Regulations and their implementation in Northern Ireland
Change made:
Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 15 January 2025
Effective field safety notices (FSNs): guidance for manufacturers of medical devices
Page summary:
Advice on writing clear notices and maximising replies to your FSNs.
Change made:
Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 15 January 2025
Regulating medical devices in the UK
Page summary:
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Change made:
Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 15 January 2025
Medical devices: post-market surveillance requirements
Page summary:
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Change made:
First published.
Time updated:
10:00am, 15 January 2025
Reporting adverse incidents involving software as a medical device under the vigilance system
Page summary:
Information for manufacturers of software as a medical device, detailing events that may cause indirect harm and are therefore reportable.
Change made:
Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 15 January 2025
In vitro diagnostic medical devices: guidance on legislation
Page summary:
Explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices (IVDs).
Change made:
Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 15 January 2025
Medical devices: how to comply with the legal requirements in Great Britain
Page summary:
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Change made:
Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 15 January 2025
Adverse incidents: in vitro diagnostic (IVD) blood glucose meters
Page summary:
Device-specific guidance for manufacturers on reporting adverse incidents under the vigilance system.
Change made:
Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 15 January 2025
Guidance on applying human factors to medical devices
Page summary:
Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
Change made:
Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024 .
Time updated:
10:00am, 15 January 2025
Implementation of medical devices future regime
Page summary:
A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition.
Change made:
Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
Time updated:
10:00am, 15 January 2025
MHRA guidance on new Medical Devices Post-Market Surveillance requirements
Page summary:
A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA).
Change made:
First published.
Time updated:
12:19pm, 15 January 2025
