Guidance

Safety communications concerning medicines, medical devices and other healthcare products

Published 25 March 2025

Background

Medicines and medical devices available to UK patients must reach high standards of safety, quality and efficacy. However, no medical product is completely free of risk. The MHRA continually monitors the safety of products, balancing their benefits and risks and communicating transparently when we identify a new safety issue. Patient safety is our highest priority, and we do not hesitate to take action to protect the public, including by promptly issuing new advice to minimise these risks or remove products from use.

We issue news, guidance and updates for the public, patients, and all of our stakeholders on the MHRA website, through the media, and via our social media accounts.

For safety issues, we will also consider releasing one or more of our safety communications. Healthcare professionals and members of the public can sign up to receive notifications when these communications are published.

In the final section of this guidance, we have provided information on the decision-making involved in issuing an MHRA safety communication.

Responsibility for actioning safety communications

All healthcare professionals are responsible for to making use of information and advice provided on the safety of medicines and medical devices used in health and social care in their treatment of and care for patients.

How to find and subscribe to our safety communications

All of the safety communications described in this guidance can be found  on GOV.UK. Please see our infographic for a step-by-step guide (download the printable version). We have also provided links to each safety communication below.

National Patient Safety Alert

National Patient Safety Alerts are used only for safety critical issues, where there is a risk of death or disability from inaction.

National Patient Safety Alerts are:

• targeted at senior leaders within health and social care organisations in England
• used for safety-critical issues that are more likely than not to cause one or more potentially avoidable deaths or disability in healthcare in England in a year
• required to contain clear, effective actions that require senior oversight and coordination within an organisation and which must be carried out by a set deadline
• assessed for feasibility, unintended consequences, equalities impact, effectiveness, and cost-effectiveness
• sent by healthcare and public-sector based organisations accredited by the National Patient Safety Committee (NaPSC), including the MHRA
• delivered in England through the Central Alerting System (CAS), a web-based cascading system

MHRA consults with representatives in Scotland, Wales and Northern Ireland before releasing a National Patient Safety Alert and the final alert is made available to them for dissemination.

Search all National Patient Safety Alerts (issued by all designated organisations) on the CAS website.

Search for existing National Patient Safety Alerts (issued by MHRA only)

Subscribe to receive notifications for new National Patient Safety Alerts (issued by MHRA only)

See guidance on the Management of National Patient Safety Alerts (open link next to ‘attachments’ to view guidance document)

Drug Safety Update

Drug Safety Updates communicate safety messages to healthcare professionals to support the safer use of medicines and other healthcare products.

Drug Safety Updates are:

• targeted at any UK healthcare professional or professional working in a management or supporting role
• used when there is a requirement for action from healthcare professionals to change their clinical practice to reduce a safety risk. This could be in prescribing, administering, or dispensing medicines, or when advising patients on safer use
• on occasion used to raise general awareness about a medicines or healthcare-related topic, for example to draw the reader’s attention to new guidance
• published on the MHRA website and the Yellow Card app
• sent to a wide range of healthcare professionals, as well as clinical guidance producers and patient and professional bodies
• collated and published in our monthly safety round up bulletin

Decisions on Drug Safety Updates are made by MHRA medicines safety specialists and clinicians, seeking advice of external experts when appropriate. Please see Process for decision-making around our safety messages for further information on this process.

Sign up to receive notifications when a new Drug Safety Update is published.

Search for an existing Drug Safety Update on our website.

Device Safety Information

Device Safety Information alerts communicate safety messages to support the safer use of medical devices.

Device Safety Information alerts are:

• issued by the MHRA when we consider that a healthcare provider, healthcare professional, or patient should take action to mitigate or minimise a potential risk identified with the safe and effective use and availability of a medical device in the UK
• on occasion used to deliver tailored advice on a safety issue that we feel is of concern to only certain groups or sectors of healthcare
• targeted at any healthcare professional, healthcare provider, medical device distributor, a user of a medical device, or those in management or supporting roles
• often used to supplement communications from devices manufacturers in Field Safety Notices (FSN) about a Field Safety Corrective Action (FSCA)
• published on the MHRA website
• issued to subscribers and cascaded to healthcare professionals through their employer or professional body
• collated and published in our monthly safety round up bulletin

Decisions on Devices Safety Information are made by internal devices safety experts and clinicians, seeking advice of external experts when appropriate. Please see Process for decision-making around our safety messages for further information on this process.

Sign up to receive notifications when a new Device Safety Information is published.

Search for an existing Device Safety Information

Recall or Notification (Medicines)

Recalls and defect notifications are used in the case of defective medicinal products. A defective medicinal product is defined as: “a product that does not comply with the marketing authorisation (specification) or Good Manufacturing Practice requirements”.

Recalls and Notifications are:

• used to alert healthcare professionals to a defective medicinal product and to advise them of actions to take to mitigate a risk
• issued by the Defective Medicines Report Centre (DMRC) within the MHRA in collaboration with the Marketing Authorisation Holder or distributor of the product
• generally targeted at pharmacists, others working in pharmacies, and also dispensing doctors, however other healthcare professionals may be listed as needing to take action to prevent a hazard

• published on the MHRA website

• issued to subscribers and cascaded to healthcare professionals through their employer or professional body
• collated and published in our monthly safety round up bulletin

The Defective Medicines Report Centre (DMRC) is part of the MHRA. The role of the DMRC is to minimise the hazard to patients arising from the distribution of defective medicines by providing an emergency assessment and communication system between manufacturers, distributors, wholesalers, pharmacies, regulatory authorities and users.

Manufacturers and distributors must report to DMRC any defect that requires healthcare professionals or patients to be notified or that could result in a recall or abnormal restriction on supply. In almost all cases the decision to recall a product or batch is made following consultation between the DMRC and the Marketing Authorisation Holder.

Manufacturers who notify the MHRA when a recall has already commenced will breach the regulations. It is not always clear whether a recall will be necessary; in these circumstances’ manufacturers should always contact the DMRC for advice. More information can be found in the DMRC guidance.

The manufacturer or distributor is responsible for recalling affected batches. The DMRC supports this action by issuing a medicines recall or notification to healthcare professionals.

Notifications and recalls are categorised according to an internationally agreed classification system.

• Class 1 – Immediate Action - The defect presents a risk of death or disability. In these cases a National Patient Safety Alert is usually issued alongside the recall.

Example scenario: Batches of a sterile intravenous medicine have become contaminated; this could potentially lead to life-threatening infections in patients.

• Class 2 – Action within 48 hours - The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious.

Example scenario: The strength of a medicine is incorrectly labelled on the packaging, this could lead to underdosing – the medicine is not used for life-threatening situations.

• Class 3 – Action within 5 days - The defect is unlikely to cause harm to the patient, and the recall is carried out for other reasons, such as non-compliance with the marketing authorisation or specification.

Example scenario: The packaging of a medicine displays an incorrect expiry date. If patients follow the incorrect date this is unlikely to cause harm.

• Class 4 – Caution in use - generally used for minor defects in packaging or other printed materials.

Example scenario: A medicine has been supplied with an older version of the Patient Information Leaflet, there is information missing which is not deemed to be critical for patient health.

• Company-led Medicines Recall/Notification - These are issued where the Marketing Authorisation Holder is able to identify the affected customers, therefore it is not necessary to issue an alert to the entire NHS/healthcare system, as the issue is only relevant to a small number of recipients.

Search for existing recalls or notifications or sign up to receive notifications when a new recall or notification is published.

Review our guidance for further information on recalls and notifications.

Safety Roundup Bulletin

At the end of every month, MHRA publishes a ‘safety roundup’ bulletin, this contains a summary of every safety alert published since the last edition including:

• Drug Safety Updates
• Devices Safety Information
• National Patient Safety Alerts
• Recalls and Notifications
• Direct Healthcare Professional Communications

The monthly bulletin allows interested stakeholders to be assured that they are up to date on all of the recent safety alerts of the MHRA in a concise and digestible format. Whilst the monthly bulletin provides a summary of each of our safety alerts, it also provides links to the corresponding full safety alert and a QR code which when scanned will allow those reading the bulletin in an offline format to access the full safety alert. A QR code is also provided for those who wish to subscribe to the monthly alert.

Additionally, the bulletin contains a ‘news roundup’ ensuring that the readership is updated on any safety adjacent news from the MHRA. Whilst the content of this changes from month to month, it may include a summary of new safety-related projects, programmes or initiatives the MHRA has been involved with or is directly working on, as well as highlighting where minor updates to healthcare product information have been completed.

Please note that our monthly round up is a new bulletin introduced as of March 2025. Previous to this date, our monthly summaries were named ‘letters and medicines recalls sent to healthcare professionals in [month, year]’ and they were published on our Drug Safety Update page. Please be aware of this when searching for articles published before March 2025 on our website.

Sign up to receive notifications when a new Safety Roundup is published

Search for an existing Safety Roundup

Safety communications from Marketing Authorisation Holders and manufacturers

Direct Healthcare Professional Communication (Medicines)

Direct Healthcare Professional Communications (DHPC) are:

• sent from the Marketing Authorisation Holder, not the MHRA
• sent to key healthcare professionals to inform them of important safety information regarding a medicine
• reviewed and agreed by the MHRA before they are sent by post or e-mail by the Marketing Authorisation Holder
• required to be clear, accessible, and targeted at the right audience, often healthcare professionals involved in prescribing or dispensing the medication
• published on the MHRA website
• collated and published in our monthly safety round up bulletin

Examples of where a DHPC might be required include:

• where a medicine has been suspended or withdrawn from the market for safety reasons
• where there has been an important change to the use of a medicine due to the restriction of an indication, a new contraindication, or a change in the recommended dose due to safety reasons
• where action has been taken to support continued supply of a medicine to the UK market
• where there are new major warnings or precautions for use in the product information
• where there is new data identifying a previously unknown risk or a change in the frequency or severity of a known risk
• where there is new evidence that the medicinal product is not as effective as previously considered
• where there are new recommendations for preventing or treating adverse reactions or to avoid misuse or medication errors with the medicinal product
• to support the dissemination of additional risk minimisation materials for the product, such as patient guides, and the implementation of the intended actions for risk minimisation in healthcare.

See our Safety Roundup for a list of DHPCs from each month (from March 2025) or Drug Safety Update for a list of DHPCs from each month (prior to March 2025).

See guidance for Marketing Authorisation Holderss on drafting a DHPC.

Field Safety Notice (Medical Devices)

Field Safety Notices (FSN) are:

• sent by a device manufacturer, or their representative, not the MHRA
• sent to customers (including healthcare professionals, distributors and retailers) to inform them of a potential safety issue involving a medical device
• used to inform customers of what action they need to carry out to reduce the specified risks of using the medical device (known as Field Safety Corrective Actions (FSCAs))
• must be notified to the MHRA before they are released unless a FSCA needs to be taken urgently
• published on the MHRA website

Examples of where an FSN might be required include:

• where a medical device has been suspended, withdrawn or recalled from the market for safety reasons
• where there has been an important change to the intended use of a medical device including a change to the indication (clinical condition the medical device is used for), a new contraindication (situation in which it should not be used)
• where there are new major warnings or precautions for use in the instructions for use of a medical device
• where there are other important updates to the instructions for use of the device such as changes to medical device handling requirements, patient monitoring requirements (for implanted medical devices), conditions for storage, maintenance requirements and compatibility requirements with other medical devices
• where there is new data identifying a previously unknown risk or a change in the frequency or severity of a known risk
• where there is new evidence that the medical device is not as effective as previously considered
• where the labelling of a medical device is found to contain errors such as an incorrect longer shelf life
• where a software update is required to correct an error in a software-based medical device which has safety implications

FSNs can be supplemented by Devices Safety Information where required.

Search for an existing FSN on the MHRA website.

Sign up to receive notifications when FSNs are published.

Review our guidance for manufacturers on effective field safety notices

Process for decision-making around our safety messages

This section covers how MHRA detects safety issues and how we review data to make decisions on whether to issue safety communications, such as Drug Safety Updates, Device Safety Information and National Patient Safety Alerts.

Data Monitoring

It is important that medicines and medical devices are monitored throughout their marketed life, including once they are on the market. MHRA monitors medicines and medical devices for safety issues.

Sources used to identify safety issues

The MHRA uses information from several sources to monitor the safety of a medicine or medical device. These include:

• spontaneous reporting schemes, for example, the Yellow Card scheme
• clinical and epidemiological studies
• worldwide published medical literature
• Devolved Administrations across the United Kingdom
• external collaborators such as Medication Safety Officer (MSO) network and Medical Device Safety Officer (MDSO) network
• marketing authorisation holder / medical device manufacturer
• worldwide regulatory authorities
• morbidity and mortality databases

Review Process

MHRA reviews information from the above sources to detect safety issues.

If a new safety issue is identified, all other relevant sources of information are gathered and reviewed as a whole. For example, if the issue is first raised through a newly published study, further data is gathered from other related studies, Yellow Card reports, healthcare databases, the Marketing Authorisation Holder / medical device manufacturer, other regulatory authorities and media reports. MHRA may also perform bespoke studies. The evidence is assessed, considering the strength of the evidence, the clinical relevance, the likely incidence of the adverse reaction or event, the exposure to the medical product and the options for mitigating the risk where necessary and/or further characterising the safety issue. This assessment is turned into a report which is reviewed by several internal medicine and medical device experts.  

Where appropriate, the MHRA seeks the views of healthcare professionals and patients on how the medicinal product is currently used and the potential impacts of the safety issue, including the lived experiences of patients who have used the product.

MHRA can also seek advice from an independent group of expert advisors, like the Commission on Human Medicines (CHM) or the Interim Device Working Group (IDWG). This may be of particular importance where:

• there may be an important public health impact,
• significant risk minimisation measures may need to be introduced that will impact on UK clinical practice,
• there is strong public concern.

Once a review is complete, if necessary, the MHRA may take action to ensure that the product is used in a way which minimises risk and maximises benefits to the patient or user. We might request that Marketing Authorisation Holders or medical device manufacturers include details of a new safety issue in the product information such as the Instructions for Use (IFU), Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC). We might also require them to take additional risk minimisation measures. In rare circumstances, we may need to recall, suspend or withdraw a product from the market, when we believe that the risks are much greater than its potential benefits. In certain circumstances we will communicate the outcome of our safety reviews in the form of a Public Assessment Report. These are published on our website.

Where we feel that healthcare professionals and other stakeholders need to be made aware of a safety issue we have reviewed, and any actions that have been taken to minimise risk, we will publish and cascade a safety communication.

The decision to issue a safety communication is discussed with internal medicine and medical device experts. The likely impacts of a safety communication are reviewed, including the benefits, and any potential risks such as reaching the wrong audience. We will also consider if the messages would be best promoted through a different means, such as through social media or contact with patient charities. We can request input from independent experts on whether to issue a safety communication where necessary.

Once it is agreed that a safety communication should be issued, a discussion takes place on which type of safety communication would be most appropriate, the appropriate timelines for publication, and any accompanying communication products (such as media communications) required to raise awareness of the communication. 

Further Information

Yellow Card scheme

The MHRA runs the Yellow Card scheme, which collects and monitors information on suspected safety concerns involving healthcare products and e-cigarettes. The scheme relies on voluntary reporting of problems by the public (including patients, parents and caregivers) as well as from healthcare professionals. The scheme also collects suspected safety concerns involving defective (not of an acceptable quality), falsified or fake healthcare products. The purpose of the Yellow Card scheme is to provide an early warning that the safety of a product may require further investigation.

Patient Information Leaflets and Summary of Product Characteristics (Medicines)

The Patient Information Leaflet (PIL) is a leaflet included in every medicine package to offer written information about the medication. The Human Medicine Regulations 2012 set out what information a PIL must contain including information on how to take the medicine and potential side effects. Patients are advised to always read the PIL that comes with their medicine.

The Summary of Product Characteristics (SmPC) is a description of a medicinal product’s properties and the conditions attached to its use. It explains how to use and prescribe a medicine. It is used by healthcare professionals, such as doctors, nurses and pharmacists.

Instructions for Use (Medical Devices)

Instructions for Use (IFU) means information provided by the manufacturer to inform the user of a medical device of its safe and proper use, of its intended performance and of any precautions to be taken.

Read further information on the Yellow Card scheme.

Read guidance for Marketing Authorisation Holders on pharmacovigilance (medicines only).

Read guidance for medical device manufacturers on vigilance (medical devices only).