The importance of physiotherapy
For athletes, being fit and healthy and keeping their bodies in tiptop condition is their main focus to ensure they play and perform at their best. Unfortunately, as any professional athlete and sportsperson will tell you, their active lifestyles come with a major occupational hazard; injury. According to Marilyn Okoro, a British Olympic athlete who competes in the 400m and 800m events, “sport and injury go hand-in-hand.” It is for that reason that physiotherapy is such key part of an athlete’s training regime, to help prevent niggles and strains, as one injury can quite literally ruin a sportspersons career.
Injuries are increasing
While injuries are a common risk for athletes, there have been rising incidences of sports related injuries in non-athletes. Taking the UK as an example, a recent One Poll study found there are 22 million sporting injuries suffered every year. This problem is also being seen in athletes. In rugby alone there has been a 20 percent rise in injuries suffered by professional players. Experts believe this increase of injuries in both athletes and non-athletes can be solved from a thorough warm-up routine before exercise and most importantly, regular physiotherapy treatments.
John Miles is the Head physiotherapist for British Rugby League team the Harlequins RL. He says as a physiotherapist, his job is to prevent what is preventable – “Yes, I can treat injuries but I spend most of my time stopping them from happening in the first place.” Miles says he often asks players to go for extra massages to help ward off injuries. “I will say, you are a speedster, so I want you to have extra physio on your hamstring to prevent a problem from occurring.”
One athlete who knows how devastating an injury can be and equally how important physiotherapy is, is Marilyn Okoro. In 2009 she suffered her first major injury; tendonopathy. With 11 inch tears in both her knees, she said the first thing she thought was, “What am I going to do now?” Okoro’s team of doctors immediately got to work to brainstorm possible treatments and therapies they could use to get her running again. “We tried to avoid surgery at all costs,” she explains. “My physio became really important to me after my injury in rehabbing me back to full fitness.”
Okoro works with Lily Devine, a UKA physiotherapist. “She is the one that hopefully prevents the injuries and when things do occur, she has various techniques she can use to overcome them,” she says. In describing the importance of physiotherapy treatments, Okoro explains: “Phsyio is massive; it is pretty much just as important as training itself. For me, at first it was really an education of how my body works and understanding my sport. I now probably have phsyio twice a week, just to stay on top of everything and to make sure no new niggles appear.”
Within the British physiotherapy scene, Sammy Margo is one of the top names as the physiotherapist to the British Football Squad. Although she has a wealth of experience in dealing with athlete’s aches and strains, she has also seen a rise in the number of non-athlete patients coming to her with musculoskeletal problems. Such a rise in sporting injuries can be blamed on the “deadly combination,” as Margo calls it, of sitting at work at a desk all day and following it with a strenuous workout. Moving swiftly from long periods of inactivity to intense exercise leaves people open to potential injury. Experts believe this is particularly the case when people fail to warm-up properly. “10 percent of a workout should be a warm-up,” Margo says. “You should also make sure you are fit and warmed-up for your sport, so if you are a runner, run; if you are doing pilates, do pre-lates to warm-up.”
Musculoskeletal Injuries often have a large economic cost. Thirty-seven percent of One Poll respondents said they had to take time off work due to an injury or strain and in some cases this recovery period lasted longer than a year.
In the UK alone, over 75 percent of people have had to take time off work because of a sports injury. Meanwhile, cases of back pain has doubled in most Westernised nations in the past 40 years. Collectively, hundreds of working days are lost every year due to injuries or chronic pain. Most of these incidences could be solved with a thorough warm-up routine before exercise and regular trips to a physiotherapist, proving it is not just athletes that need to take care of their muscles. Sammy Margo concludes by saying: “You visit the dentist and hygienist to get your teeth checked out, so why not go to a physiotherapist to get your body checked?”
Marilyn Okoro talks about victory at the UK Indoor Championships after injury:
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.