Question to the Department for Business and Trade:

To ask His Majesty's Government what allowance is made under the Companies House requirement for company directors to verify their identity online, or by starting the process on-line, for those who do not have access to the internet or the ability to apply in this way.

Answered by Baroness Lloyd of Effra - Baroness in Waiting (HM Household) (Whip)

Companies House have invested in expansion and training of our customer service team to assist users in their identity verification journey. This includes establishing a specialist team to support customers who have accessibility requirements.

Users can ask someone they know to help them prove their identity: https://www.gov.uk/guidance/help-someone-use-govuk-one-login. Where identity cannot be verified online, users may be directed to complete the process in person at a participating Post Office. The invitation to initiate this journey can be issued via post.

Authorised Company Service Providers may also offer non-digital identity verification services.

Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of the public health risks posed by illegal online sales of optical appliances, particularly for children and other vulnerable groups.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

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.

Question to the Department of Health and Social Care:

To ask His Majesty's Government what steps they are taking to ensure a level playing field for UK-based optometry practices and regulated optical business that provide compliant contact lens sales, in the light of unregulated overseas websites selling lenses in the UK.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

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.

Question to the Department of Health and Social Care:

To ask His Majesty's Government what plans they have to (1) extend regulatory powers, (2) improve reporting mechanisms, and (3) work with (a) online platforms, (b) manufacturers, (c) professional bodies, and (d) enforcement agencies, to address the illegal online sale of optical appliances.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

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.

Question to the Department of Health and Social Care:

To ask His Majesty's Government what steps they are taking to strengthen enforcement against the illegal online sale of optical appliances, including by overseas suppliers operating in the UK market.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

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 establish the statutory framework that medical devices must meet in order to comply with these standards.

Optical appliances as medical devices must comply with requirements set out in the regulatuons, which include bearing the UKCA or CE marking on the packaging or labelling of the device. Manufacturers based outside of the United Kingdom must have a UK responsible person, and all devices must be registered with the MHRA prior to being placed on the market. Manufacturers or their UK representatives must also monitor use of these devices when used in the UK and report serious incidents to the MHRA.

The MHRA ensure that medical devices placed on the market and put into service in the UK meet these regulatory requirements by: assessing all allegations of non-compliance brought to us, using a risk-based system; monitoring the activity of UK approved bodies we designate 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 that a product is breaching the medical devices regulations, typically, the MHRA Devices Compliance Unit will contact the manufacturer or, if the manufacturer is based outside of the UK, the UK Responsible Person, outlining the agency’s 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 is available at the following link:

https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/how-mhra-ensures-the-safety-and-quality-of-medical-devices

In addition to our investigatory and enforcement activities, the MHRA maintain ongoing relationships with external stakeholders including 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.

Question to the Department of Health and Social Care:

To ask His Majesty's Government whether they plan to update medical device regulations to bring UK-based online contact lens retailers under a clear regulatory framework; and whether they plan to introduce measures including (1) a recognised compliance mark, (2) stronger border controls, and (3) oversight to ensure customers identify lawful suppliers and reduce the risk of eye infections.

Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)

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.

Opthalmic 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 use of these devices when used in the UK. Allegations of deficiencies that do not meet these standards must be reported to the MHRA through the Yellow card scheme or informed though published guidance, with further information available on the GOV.UK website.

The MHRA is not responsible for the movement of medical devices across borders.