Fit for Business
Companies are leading the way in ‘duty of care’ towards their employees, offering health, fitness and wellbeing plans in the workplace, but are these simply short-term solutions? Or do they encourage an overworked nation to establish a work/life balance?
While our awareness of keeping fit and healthy has increased, it has also extended into the workplace, encouraged by schemes like those run by Corporate Fitness Works. They serve the health, fitness and recreation needs of businesses and industries in the US, and are certified by the American Council on Exercise (ACE). The non-profit fitness advocate also promotes the benefits of physical activity, a lifeline in a country where obesity is now an epidemic.
According to a report by the BBC in March 2004, obesity costs American companies US$13billion a year, a figure which could do with trimming down. However, employee wellness schemes in the US are paying off, literally. A study by CBS Evening News in January 2007, showed that for every one dollar organizations spend on employeesí health, they can save three dollars in health care.
Speaking to Grant Thornton about its wellbeing policy during the company’s National Wellbeing Week, Margaret Bowler, Head of CR, explained, “We want to create an environment where our people are aware of their own responsibility for their health and safety, and their wellbeing – we will facilitate it, and encourage it, and give them all the tools they need for it.”
Bowler was keen to emphasize that the aim of all this is not to create a “nanny state” but simply an awareness, so that the responsibility lies equally with the employer and employee. According to Bowler, Grant Thornton is not telling its employees they have to exercise but gently reminding them. A number of themes such as exercise, nutrition, mental wellbeing, physical wellbeing, and fitness, drive the activities that take place throughout the company’s offices.
Grant Thornton has identified two major risks that it feels its employees are subject to in the office environment: multiskeletal disorder and stress. In fact, Bowler believes that multiskeletal disorders are “the asbestos of the future”. With most of the population owning a laptop, the Head of CR is convinced that lack of training is doing irreparable damage to the back that will cause problems later in life, “I don’t think we’ve yet seen the repercussions of that from an employment perspective,” she adds.
Like Grant Thornton, White Water Strategies is focused on exercise and physical alignment, along with nutrition, rest and relaxation, all of which come together to form what Director Averil Leimon describes as “a corporate athlete”, or “a model of human excellence”. “It’s a survival strategy because it’s tough out there and it’s not going to get any less challenging and people need to be honed for action,” she explains.
In the current climate particularly, increased health, fitness and wellbeing could indeed reduce the risk of stress in the workplace. For Leimon, it is a particularly important and interesting time, “At the moment many of the people reaching senior posts have not been through a downturn. They haven’t dealt with the depressed market, they haven’t dealt with not having success at every turn.” As Leimon sees it, “In order for businesses to come through the tough markets ahead , they need their people to be resilient and fit to lead - that will protect the individual and give the organization the best chance of success and survival”.
Survival of the fittest
Leimon recalls how similar workplace strategies were alive and well decades ago, “I started working in the stress field in the early 80s, and there were fabulous companies then. As well as doing health and stress management, there were some very innovative things going on that long ago.” She argues that the requisite gym memberships offered by organizations today, simply ‘tick a box’, as companies vie to demonstrate concern for employees’ mental and physical fitness in order to avoid litigation. White Water Strategies takes a more realistic approach, realizing that most business leaders do not want a 50/50 work/life balance as such, the firm helps business leaders discover those aspects of life that sustain them.
Certainly it is all too easy to take a cynical view of an organization’s increasing interest in its employees’ health. Leimon sees two sides to it, “On the one hand there’s the understanding that if people are healthy they’re going to function better. There is also the negative side that people want not to be faced with litigation for stress, for instance. I think there are some places with a growing awareness, but there’s a long way to go.”
At Grant Thornton, Bowler explains her theory behind employers’ increasing need to demonstrate a duty of care to their employees, “I think it reflects society that people want different things from their employer – it’s a badge of who they are, and they want to work with the organizations that care about the impact they make on people as individuals.”
For now, as long as health schemes offered by organizations are well-managed, and feedback from employees is monitored, there is no reason why an increased awareness of managing health and wellbeing in the workplace should not become standard practice among employers.
Medical device companies: how to prepare for Brexit
Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.
The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.
The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.
The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline.
This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:
Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking.
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.
Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.
For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established.
Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users.
While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.
Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.
Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.
As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.