Scleral contact lenses can be funded by the National Health Service for hospital eye service patients if there is a clinical need.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring that medicines, medical devices, and blood components for transfusions on the market in the United Kingdom are safe, effective, and manufactured to the highest standards of quality. The Medical Devices Regulations 2002 (MDR 2002) establish the statutory framework that medical devices must meet in order to comply with these standards.

Optical appliances as medical devices must comply with the MDR 2002, which include bearing the UKCA or CE marking on the packaging or labelling of the device. Manufacturers or their UK representatives must also monitor the use of these devices when used in the UK and report serious incidents to the MHRA. Allegations of deficiencies and incidents that do not meet these standards must be reported to the MHRA through the Yellow card scheme or informed though published guidance around enforcement and compliance.

The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that medical devices placed on the market and put into service in the United Kingdom meet these regulatory requirements by:

- assessing all allegations of non-compliance brought to us, using a risk-based system;

- monitoring the activity of the UK approved bodies we designated to assess the compliance of manufacturers; and

- investigating medical devices as a result of adverse incident reports or intelligence indicating a potential problem.

If the MHRA considers a product to be breaching the medical devices regulations, typically, the MHRA’s Devices Compliance Unit will contact the manufacturer or, if the manufacturer is based outside of the UK, The UK Responsible Person, outlining our concerns and requesting further information with a view to bringing them into compliance.

If a manufacturer fails to co-operate with our requests and continues to place a non-compliant product on the market, or there is a serious risk to public health, the MHRA may consider using our enforcement powers. Guidance on how we enforce medical device regulations can be accessed on the GOV.UK website, in an online only format.

In addition to our investigatory and enforcement activities, the MHRA maintains ongoing relationships with external stakeholders, including other Government enforcement agencies and major online selling platforms to address non-compliant listings of medical devices available on the UK market, including those listed on overseas websites. This collaboration typically involves reporting mechanisms and proactive engagement with external online platforms to identify, address, and prevent non-compliant listings.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the regulation of medicines for human use, medical devices, and blood products for transfusion in the United Kingdom. This includes applying the legal controls on the retail sale, supply, and advertising of medicines which are set out in the Human Medicines Regulations 2012.

Sourcing medicines from unregulated suppliers significantly increases the risk of getting a product which is either falsified or not authorised for use. Products purchased in this way will not meet the MHRA’s strict quality and safety standards and could expose patients to incorrect dosages or dangerous ingredients.

Public safety is the number one priority for the MHRA, and its Criminal Enforcement Unit works hard to prevent, detect, and investigate illegal activity involving medicines and medical devices and takes robust enforcement action where necessary. It works closely with other health regulators, customs authorities, law enforcement agencies, and private sector partners, including e-commerce and the internet industry to identify, remove, and block online content promoting the illegal sale of medicines and medical devices.

The MHRA seeks to identify and, where appropriate, prosecute online sellers responsible for putting public health at risk. Last year, the MHRA and its partners seized more than 17 million doses of illegally traded medicines, including those usually issued on prescription. Additionally, the MHRA has also disrupted thousands of links to websites and social media pages selling medical products to the public illegally.

The MHRA’s FakeMeds campaign provides advice to people in the UK who are considering buying medication online, outlining how products can be accessed from safe and legitimate source.

Anyone who believes they’ve had a side effect from a medicine, or who believes they’ve received falsified stock, can report it to the MHRA’s Yellow Card scheme.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for monitoring the safety of all healthcare products in the United Kingdom.

The MHRA has investigated acanthamoeba keratitis infections associated with water and contact lenses and has reviewed the instructions for use for all contact lenses on the UK market. While some already provide appropriate warnings and preventative advice, others require improvement. We are considering how best to achieve this under the powers being created for the new UK medical devices regulatory regime and as we address recommendations from the Independent Medicines and Medical Devices Safety Review.

We have also worked with various stakeholders and patient representatives to provide information to the public on the risks associated with acanthamoeba keratitis infections.

This engagement has resulted in information for contact lens users being provided on the MHRA’s website.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for monitoring the safety of all healthcare products in the UK.

Following reports of infections that have led to sight loss due to Acanthamoeba Keratitis (AK), the MHRA participated in the Love your Lenses Campaign organised by the General Optical Council with involvement and support from manufacturers and opticians. The main aim of this campaign is to increase the effectiveness of aftercare information given to contact lens wearers. Details of the campaign can be found at the following link:

https://www.loveyourlenses.com/

The MHRA’s website also highlights the risks of AK and offers guidance and advice for patients to prevent injury and infection. The website can be found at the following link:

https://www.gov.uk/guidance/medical-devices-information-for-users-and-patients

In the United Kingdom, the Opticians Act restricts the sale and supply of contact lenses, including ‘zero powered’ (plano) contact lenses, to registered optometrists, dispensing opticians, and medical practitioners. An optometrist examining a patient wishing to wear contact lenses has a duty to assess the patient's suitability for contact lenses and provide the patient with an appropriate lens care regimen, including information on the care, wearing, treatment, cleaning and maintenance of the lens or lenses.

No estimation has been made of the number of people with eye infections caused by sub-standard contact lenses.

Prescription contact lenses must comply with the Medical Devices Directive and must carry a CE marking to denote compliance with the Directive.

There are no smart contact lenses currently licensed for use in the United Kingdom for the monitoring of blood sugar level in people with diabetes. Before a marketing authorisation - or licence - can be granted for a medical device, an application needs to be made, supported by data demonstrating that its quality, safety and efficacy are satisfactory and that the risk to benefit profile is favourable for the proposed treatment.

However, we are very interested in the development of smart contact lens technology and whether, in the future, it may have potentially beneficial applications within the National Health Service for people with diabetes.