Tag Archives: HM Government

From sticking plasters to hip replacements, contact lenses to implanted pacemakers, medical devices are a part of everyday life. To make sure these medical devices are acceptably safe and perform as intended, they must comply with the relevant EU legislation.

The Medicines and Healthcare products Regulatory Agency (MHRA) has created an introductory guide to make sure manufacturers are aware of their obligations under the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR).

Entering into force on 25 May 2017, the three and five year transition periods (also known as implementation) are now underway; the new regulations will apply across EU Member States from 26 May 2020 and 2022 respectively.

The Introductory Guide, designed as an interactive pdf, will help new manufacturers who may be looking at the regulations for the first time, and will also help experienced manufacturers navigate the changes in the new regulations.

The new regulations will include clearer obligations for those involved in manufacturing and supplying devices, a greater emphasis on traceability throughout the whole supply chain with the introduction of a unique device identification (UDI) system and new standards for clinical evidence. They also set out more rigorous vigilance reporting requirements, including new reporting timescales, as well as clearer requirements on what a manufacturer’s post-market surveillance system should comprise of. The new regulations are a balancing act of proportionate responsibility and an increasingly technological approach to healthcare.

Some products will become regulated under medical device legislation for the first time. Annex XVI of the MDR lists six categories of products similar to medical devices that do not have any medical benefit and are used for other purposes, such as dermal fillers, non-corrective contact lenses and brain stimulation devices. These products carry much of the same risks as medical devices and – under these new Regulations and detailed ‘Common specifications’ to be published by the European Commission – their manufacturers, importers and distributors will be regulated in the same way.

John Wilkinson, MHRA’s director of Medical Devices said:

We live in an increasingly digital world, and the way we provide our guidance is changing. We want to help manufacturers to comply with the new regulations as easily and as early as possible.

Our guidance is designed for all users – to help experienced manufacturers navigate the increased requirements for devices and diagnostics, as well as those manufacturers who will be new to the medical device regulations as a result of the broader scope of the new legislation.

Patient safety is our priority. It is expected that the implementation of these new regulations will clarify the role of competent authorities increase post-market surveillance to help protect both patients and industry alike.

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Work to transform Euston station into a gateway to the capital fit for the 21st Century and deliver a brand new transport hub at Old Oak Common ready for the arrival of High Speed Two (HS2), took a step forward today with the start of the search for the firms that will build the 2 London stations.

The announcement comes after the closure of Euston station over the weekend for essential HS2 preparatory works. The works were completed on time allowing services to run as scheduled on Bank Holiday Monday.

Overall, the investment at Euston and Old Oak Common is expected to help unlock 79,000 jobs and 29,000 homes around the stations, attracting businesses and housing developers to what will be some of the best connected locations anywhere in the UK. Contracts for HS2’s Birmingham stations, that are expected to unlock close to 52,000 jobs and almost 6,000 new homes, will follow in 2018, with all the new stations ready to welcome their first passengers in 2026.

HS2 services will eventually connect over 25 destinations and 30 million people across the UK. Trains will serve existing city centre stations in places like Glasgow and Liverpool, as well as brand new purpose built stations in Birmingham, Manchester, Leeds, and the East Midlands.

Transport Minister, Paul Maynard, said:

The launch of the search for construction teams to build the southern HS2 stations is another major step towards making Britain’s new railway, a catalyst for growth across the country. And next year HS2 Ltd will begin the hunt for companies to build the 2 Birmingham stations.

The winning bidders will need to ensure that the stations provide the best possible customer experience. But there will also be huge and exciting opportunities for development around all HS2 station sites, not just in London and the West Midlands, but also in Manchester, Leeds, Sheffield, and the East Midlands, unlocking huge opportunities for new jobs, homes and economic growth.

HS2 Ltd Chief Executive, Mark Thurston, said:

Launching this competition is another major milestone for HS2. Over the next decade, the successful bidders will go on to build 2 of the most challenging and high profile elements of the project; a brand new transport hub at Old Oak Common that will kick-start the regeneration of the site plus a major expansion of Euston.

We’re looking for the best the construction industry has to offer. Companies that share our commitment to safety, efficiency, environmental protection and value for money. Together we will create 2 iconic stations, gateways to the capital and to the nation that local communities and the travelling public can be proud to call their own.

Working with HS2 Ltd and the Euston and Old Oak Common designers, the successful bidders will act as construction partners, responsible for programme management as well as procuring, integrating and managing the complex supply chains.

It is expected that around 4,000 jobs will be supported during construction of the 2 stations, with around 700 during operation.

At Old Oak Common, HS2 will deliver a brand new integrated transport hub boasting some of the best connections anywhere on the network, with direct HS2 services to destinations including Liverpool, the North West, Glasgow and Edinburgh. New platforms will also allow passengers to connect to Crossrail, for Heathrow and the City of London, as well as services to Wales and the West of England.

The wider transformation of the former railway sidings and light industrial zone is being led by the Mayor of London’s Old Oak and Park Royal Development Corporation, which aims to create a thriving new community with up to 65,000 jobs and 25,500 new homes.

At Euston, 11 new platforms, built in 2 phases, will nearly triple capacity, improving people’s journeys and providing the opportunity for sustainable mixed use development on the site which could support up to 14,000 new jobs and almost 4,000 new homes.

The staged approach to building the high speed terminus means existing services can continue to operate, reducing both disruption for passengers and the effects on the community as a whole at any one time.

As well as improving journeys for long-distance travellers, HS2 will also open up extra capacity for commuters travelling in from places like Milton Keynes and Northampton and deliver a revamp and expansion of the London Underground station, linking Euston and Euston Square into 1 station for the first time, and providing a new ticket hall and provision for a potential future connection to Crossrail 2.

Bidders for both contracts are expected to be invited to tender by the end of the year, with contract award in autumn 2018. Market engagement has already begun for the Birmingham stations and the procurement process is expected to begin early next year with contract award in 2020.The procurement process for the construction of the Birmingham stations, which have shorter lead-in times, is expected to begin in 2018 with contracts awarded in 2020.

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HM Land Registry Price Paid Data tracks land and property sales in England and Wales submitted to us for registration.

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The Minister’s visit is the latest in a series of high-level UK visits to Astana during EXPO-2017, the international exhibition to promote safe and sustainable access to energy and reduce carbon emissions, of which the UK is a major participant. Kazakhstan is the fastest growing economy in Central Asia and a valued trade partner for the UK, with the UK’s foreign direct investment to the country reaching more than US$25 billion since Kazakhstan gained independence in 1991.

During his visit, Sir Alan Duncan will deepen the UK–Kazakhstan relationship, focusing on our shared commitment to international security; promoting of our strong trading relationship; and welcoming Kazakhstan’s commitment to ongoing economic and judicial reforms. In support of those reforms, the Minister will announce UK funding of £74,000 to help Kazakhstan implement its Anti-Corruption strategy.

The Minister will meet the Prime Minister of Kazakhstan, Bakytzhan Sagintayev and Foreign Minister Abdrakhmanov and host a reception for local civil society and UK Chevening scholarship alumni. The Minister will also give a speech on the United Kingdom’s global role at the Library of the First President and tour the capital, Astana, to highlight UK architecture expertise.

Speaking ahead of the visit, Sir Alan Duncan said:

I am delighted to visit Kazakhstan as it celebrates Constitution Day. I extend my warmest wishes to the people of Kazakhstan on this special occasion.

Kazakhstan is an important partner for Britain. I look forward to productive discussions with Prime Minister Sagintayev and Foreign Minister Abdrakhmanov. Kazakhstan has an important role to play on the global stage, including during its tenure on the UN Security Council.

As one of Kazakhstan’s top six investors, the UK supports economic and judicial reform in Kazakhstan. I am confident they will help boost Kazakhstan’s future prosperity and democracy. In that vein, I am pleased to be able to visit EXPO 2017 and look forward to seeing a number of pavilions.

2017 marks the 25th anniversary of UK – Kazakhstan diplomatic relations. I am pleased our cooperation is as strong as it has ever been and, I am sure, will continue to flourish. More than ever before the UK is open to the world and seeks to strengthen further its relationship with countries across the globe.

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• New laws will force all listed companies to reveal the pay ratio between bosses and workers
• All listed companies with significant shareholder opposition to executive pay packages will have their names published on a new public register
• New measures will seek to ensure employee voice is heard in the boardroom

For the first time listed companies will have to publish pay ratios between chief executives and their average UK worker under government reforms to boardroom accountability outlined today (29 August 2017).

Business Secretary Greg Clark today set out how the Government’s package of corporate governance reforms will enhance the transparency of big business to shareholders, employees and the public.

These will include the world’s first public register of listed companies where a fifth of investors have objected to executive annual pay packages. This new scheme will be set up in the autumn and overseen by the Investment Association, a trade body that represents UK investment managers.

In the coming months the Government will introduce new laws to require: * around 900 listed companies to annually publish and justify the pay ratio between CEOs and their average UK worker * all companies of a significant size to publicly explain how their directors take employees’ and shareholders’ interests into account * all large companies to make their responsible business arrangements public

Last year the Prime Minister made clear that the behaviour of a small number of companies had damaged the public’s trust in big business. She set out proposals to improve transparency and accountability and give employees a voice in the boardroom. The reforms announced today follow a thorough consultation process.

Business Secretary Greg Clark said:

One of Britain’s biggest assets in competing in the global economy is our deserved reputation for being a dependable and confident place in which to do business. Our legal system, our framework of company law and our standards of corporate governance have long been admired around the world.

We have maintained such a reputation by keeping our corporate governance framework under review. Today’s reforms will build on our strong reputation and ensure our largest companies are more transparent and accountable to their employees and shareholders.

The Business Secretary will seek to ensure employees’ interests are better represented at board level of listed companies. He will ask the Financial Reporting Council (FRC), which sets high standards of governance through the UK Corporate Governance Code, to introduce a new requirement in the code to achieve this.

Under the code’s “comply or explain” basis, firms would have to either: * assign a non-executive director to represent employees; * create an employee advisory council; * or nominate a director from the workforce.

The FRC will also be asked to work with the business community and the Government to develop a voluntary set of corporate governance principles for large private companies.

Stephen Haddrill, CEO of the FRC, said:

The UK’s deserved reputation for good corporate governance, earned over the last 25 years, has underpinned British business success. How we develop the framework will be key to boosting competiveness, transparency and integrity in business particularly after Brexit. Successful and sustainable business are not just good for the economy, they support wider society by providing jobs and helping to create prosperity.

The FRC is undertaking a fundamental review of the Corporate Governance Code. The Government’s feedback will help inform the development our consultation later this year.

Large private companies are integral to the UK economy as significant employers and supporters of communities and families. It is right that we develop a set of corporate governance principles to enhance confidence that they act in the public interest.

The Government intends to bring legislative reforms into effect by June 2018.

Responding to the Government’s responsible business reforms, Stephen Martin, Director General of the Institute of Directors, said:

We welcome the pragmatic approach the Government is taking to improve how company boards work. We’re particularly pleased that there will be a code for large private businesses, as the principles of good governance should extend beyond the companies listed on the stock market.

The Secretary of State is taking a sensible approach on giving workers a bigger say, by allowing companies to choose the best way to implement the new rules. All directors are responsible for the whole company, so any with the specific remit to speak for employees must be adequately trained and aware of their responsibility to promote the long-term success of the business.

Pay ratios will sharpen the awareness of boards on the issue of remuneration, but they can be a crude measure. Companies will have to prepare themselves to explain how pay as a whole in their business operates, and why executives are worth their packages.

Terry Scuoler, Chief Executive of EEF, the manufacturers’ organisation, said:

UK Manufacturers have a strong track record of good corporate governance and high standards of employment practice with many examples of excellent employee engagement in firms up and down the land.

These proposals will build on these existing high standards, spreading best practice, improving transparency and ensuring greater consistency amongst the UK’s largest businesses.

The reforms, which will accelerate improvements in Corporate governance, are consistent with the UK’s industrial strategy and will aid international competiveness and attractiveness as a hub of global trade and investment.

Paul Drechsler CBE, Confederation of British Industry President, said:

Good corporate governance is an essential ingredient of business performance and the bedrock of trust between business and society.

We know that how companies act and behave determines the way people think about business.

Companies take this seriously and we look forward to working closely with the Government to ensure the UK maintains its reputation as a global leader in this field and as a primary location for international investment.

The CBI is very clear that the unacceptable behaviour of a few firms does not reflect the high standards and responsible behaviour of the vast majority of companies.

Commenting on the new public register, Chris Cummings, Chief Executive of the Investment Association, said:

The creation of the public register on shareholder voting is an important step in increasing accountability and transparency of those listed companies that see significant shareholder rebellions during the AGM season.

Our members, who manage the pensions of 75% of UK households and own over one third of the FTSE, believe that not all company boards that receive big shareholder dissent are currently doing enough to address investor concerns. This public register will help sharpen the focus on the those who must do more, enabling our members to hold the country’s biggest businesses to account and leading to better-run companies.

We look forward to working with Government to deliver the public register and aim to launch it later this Autumn.

Stefan Stern, director of the High Pay Centre think-tank, said:

We want investors and boards to ‎have a more constructive and more thoughtful conversation on executive pay, and this sort of public disclosure should help.

This is a step in the right direction, providing greater transparency and focusing the public’s attention on those companies who ignore the concerns of their shareholders.

Notes for Editors

1. Corporate Governance Reform: government response (PDF, 647KB, 69 pages)

2. The FRC intends to consult on amendments to the UK Corporate Governance Code in late autumn with a view to publishing a revised code by mid-2018. This would mean the code would apply to the majority of companies in 2019
3. The government today announced its intention to fulfil its manifesto commitment to examine the use of share buyback schemes, where companies repurchase their own shares, to ensure the method is not being used to artificially influence executive pay performance targets
4. In the coming weeks, Business Minister Margot James is expected to chair the first ever meeting of the Business Diversity and Inclusion Group, set up to make sure government and industry work more closely to remove barriers in the workplace. The group will bring together the leaders of four industry-led diversity reviews:
   • Sir Philip Hampton, chairman of a review into increasing female representation at the top of business
   • Baroness McGregor-Smith, who led a review into BME participation and progression in the workplace
   • Sir John Parker, who is leading a review into diversity on boards
   • Jayne-Anne Gadhia, Government champion for women in finance

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