The Truth About Going Under the Knife
Question and Answer
Dr Carl Heneghan, Clinical Reader and Director of the Centre for Evidence-Based Medicine, University of Oxford (www.cebm.net)
What is a medical device?
A medical device is any instrument, appliance or computer software that is intended by its manufacturer to be used for diagnosis and/or treatment in humans.
Medical devices are specifically designed and used for the following purposes:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease, symptoms of disease or disability
- Investigation, replacement or modification of the anatomy of the body or of physiological process
- Control of conception
There are three categories of medical device:
- Class 1: Devices that pose the lowest risk, such as wheelchairs, hospital beds, thermometers, and so on
- Class 2: Medium risk devices, such as endoscopes, blood pressure monitoring devices, X-ray imaging devices, and so on
- Class 3: High-risk devices, such as artificial joints, implantable defibrillators, pacemakers, and so on
Who regulates medical devices?
A national regulator called the Medicines and Healthcare Products Regulatory Agency (MHRA) oversees the process of classifying a medical device in the UK (www.mhra.gov.uk).
Each European country has its own unique regulator.
How do I find out if a medical device has been recalled?
You can use the MHRA's website to search for safety warning, alerts and recalls.
Information on devices before 2006 is not available on this site.
What sort of problems should be reported?
You should report any incident that has caused unexpected or unwanted effects directly involving a medical device. This may be for a medical device you use or have implanted, or it may be for a medical device used or implanted in someone that you care for.
What should be reported?
You should report all unexpected or unwanted effects involving a medical device even if the event is a minor one.
How do I report a problem with a medical device?
To report a problem you should go to the following MHRA website:
This website provides clinicians, patients and members of the public all the relevant information to be able to report a problem. Online reports may be submitted securely via the MHRA website at any time of any day.
General reporting enquiries should be directed to the MHRA Adverse Incident Centre:
Email: aic@mhra.gsi.gov.uk
Phone: 020 3080 7080
Who should report a problem with a medical device?
Anyone can submit a problem with a medical device to the MHRA. This includes clinicians, healthcare workers, carers, patients and members of the public.
What is A Medical Device alert?
Medical Device Alerts are the MHRA's way of communicating safety information
What is a field safety notice?
The European Medical Devices Directives require manufacturers to monitor the safety of their products and, where necessary, carry out corrective actions on medical devices.
Field Safety Notices are issued by a manufacturer when a medical device needs to be recalled for technical or medical reasons.
The Medicines and Healthcare products Regulatory Agency (MHRA) published manufacturers' Field Safety Notices on its website: www.mhra.gov.uk
How does the European Union classify medical devices?
To be available for use for a medical purpose, a device needs to be correctly marked according to European Union directives with a Conformité Européenne (CE) mark.
What does a CE Mark look like?
The CE marking has to be fixed to the product, its packaging or to the accompanying documents.
Do countries outside the European Union have regulation on medical devices?
Many other countries such as Australia, Canada, Japan and the USA have their own systems for regulation of medical devices. For example, in the US, the Food and Drug Administration (FDA) publishes a list of recalled devices and the regulatory processes.
What are Notified Bodies?
The approval of medical devices is overseen by the MHRA. The MHRA certifies notified bodies, which are for-profit organisations authorised to approve devices and grant a CE-mark.
In the European Union there are 74 separate notifying bodies authorised in 25 countries to approve medical devices - six of these are the UK.
Under the current system, a manufacturer selects a notified body to undertake the process of certifying a new device for CE marking allowing the device to be sold to the whole of the European market.
Once the CE marking is approved in one country the device is automatically approved for all of the 25 European countries.
