MHRA Yellow Card Scheme
What is the Scheme?
The Yellow Card Scheme is run by the Medicines and Healthcare Products Regulatory Agency (MHRA).
The scheme is used to collect, collate, and investigate reports of suspected side effects to medicines, vaccines, e-cigarettes, medical device incidents, defective or falsified (fake) products. The scheme is not new – it was first established in 1964 in response to the thalidomide tragedy, which highlighted the urgent need for routine independent monitoring of the safety of medicines by a central body. The scheme relies solely on the voluntary reporting of problems by the public (including patients, parents, and caregivers), as well as from healthcare professionals.
Why is it important for me to know about the scheme?
The seventh annual #MedSafetyWeek took place from 7th to 13th November 2022, with a particular focus this year on the importance of reporting suspected adverse reactions to medicines and vaccines. However, this week was also used to encourage the reporting of suspected problems with medical devices or other healthcare products, via the Yellow Card Scheme.
During #MedSafetyWeek, healthcare professionals were asked by the MHRA to support the campaign, talk to their patients and colleagues about side effects, and how they can report suspected problems to the Yellow Card Scheme. It was all about helping MHRA to monitor the safety of healthcare products that are on the UK market.
To help ensure the success of the campaign, the MHRA published an dedicated page on their website here, and an update to the UK government website was also made here.
The MHRA also launched the Yellow Card Scheme app for IOS and Android some time ago, to help make reporting quicker and easier for people to inform them of issues. Of course, the main website is still a primary route for users etc to report issues. There is even a YouTube video to guide you on ‘how to report a problem with a medical device’ here, with a dedicated page for information to users about adverse incidents with medical devices here.
The key takeaway from the campaign for you as a medical device manufacturer is that they are asking people to report any adverse incidents associated with a medical device through the Yellow Card scheme. This means they any incident with any device, instrument, or appliance (including software), used alone or in combination, which is intended by the manufacturer to be used for the diagnosis, prevention, treatment or alleviation of a medical condition. This also includes reporting potential problems with medical devices.
Impact Assessment
What does this mean for you?
Well, as the campaign week has passed, unless you have been contacted by MHRA as a result of their receipt of Yellow Card Reports, then in fact very little…. but it does mean that you should take time to understand the process, and to make sure that your organization is in fact ready to handle any communications with MHRA in this regard.The MHRA has over the years made it easier for users to report adverse incidents with medical devices, and implemented several initiatives to improve/increase reporting, and this will continue to increase no doubt. This therefore has the potential for you to be contacted more frequently by MHRA regarding your devices, so what can you do to be ready?
One of the positive results from these types of campaigns is the increase in the knowledge of the public about the Yellow Card Scheme. This in turn may mean that the MHRA receives more Yellow Card reports from users (valid or not… ), and of course this in turn may mean that the MHRA will send more adverse incident reports to manufacturers.
In order to be ready to act in a timely manner, we would recommend that you:
- Read the previous links in this document and understand the process for the Yellow Card Scheme.
- Check that your organization is set up to receive adverse incident reports from MHRA
- Ensure that the contact email address you have provided is monitored frequently (to ensure timely review of any adverse incident reports)
- Ensure any employee knows what to do if they receive an adverse incident report communication from MHRA
- Ensure that your MORE account with MHRA is up to date and readily accessible
- Read and understand MEDDEV 2.12-1 rev 8 (Medical Devices Vigilance Guidance Document
- Ensure that you can receive back the reported device for your investigation if needed (infrastructure, PPE, staff training, QMS, etc.)
Final Thoughts
In my personal experience working in QARA for a medical
device manufacturer, I received several adverse incident reports from MHRA
which were not my company’s products, or not at all meeting the criteria of an
adverse incident, however these were still sent to me from MHRA, and we still
had to review, investigate, and respond as appropriate, so the I would say ‘be
prepared’, as the quantity of adverse incident reports you receive may
increase, even if the process still needs some refinement!
If you do receive an adverse incident report, and need support in deciding what to do next, don’t hesitate to contact us and we can help guide you through
James Bradbury
Compliance and Training Delivery Manager
