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.
The 5 most successful COVID-19 vaccine rollouts
Bhutan recently announced it had fully vaccinated 90% of its population within just seven days of launching its vaccine drive. What made this so successful, and which countries round the world have delivered the most efficient vaccination programmes? Healthcare Global takes a look at the top 5.
Bhutan has very quickly become the nation with the most successful vaccine rollout. The tiny Himalayan country has a population of 800,000, and has reported 2,518 infections and two coronavirus-related deaths since the start of the pandemic.
In April, India donated 550,000 doses of the AstraZeneca vaccine, but had to pause its supply as infections increased, leading to a rise in demand. In July Bhutan restarted vaccine distribution after 500,000 doses of Moderna were donated by the US under the COVAX programme, and a further 400,000 doses of AstraZeneca arrived from Denmark, Croatia and Bulgaria.
As well as highlighting the importance of wealthier nations donating vaccines to countries that need them, Bhutan's government counts several doctors among its members, including the Prime Minister Lotay Tshering. This has helped tackle vaccine hesitancy - with regular government announcements and answering citizen's questions on platforms like Facebook.
United Arab Emirates (UAE)
The UAE has fully vaccinated 71% of its population. The first vaccine to become available here was Sinopharm, manufactured in China, a major buyer of UAE oil. The two nations struck a partnership to produce the vaccine locally in the UAE. After this Pfizer-BioNTech, Oxford-AstraZeneca, and Russia’s Sputnik V vaccine also became available free of charge.
To date the UAE has had 682,000 reported cases of COVID-19, and 1,951 deaths. It was the first country in the region to report cases of coronavirus, and the government implemented swift public measures including a strict lockdown and drive-through PCR testing to keep infection rates under control - the number of PCR tests conducted reached more than double the population in January 2021.
In 2020 Uruguay was hailed as a success in terms of its COVID-19 response. Despite sharing a border with Brazil, which has seen one of the world's worst rates of infection, COVID-19 cases were low thanks to a very efficient testing programme, reporting only 1,400 cases by June 2020.
These statistics changed dramatically this year when the government decided to drop COVID-19 restrictions and rely on vaccinations; as a result Uruguay now has the world’s fifth-highest death rate, and the highest in Latin America.
However it does have the second-fastest vaccination rollout in the continent, with 64% of the population fully vaccinated. In June it also began giving vaccines to people aged 12 to 17.
Experts are hopeful this speedy vaccination programme will stem the rise in infections. Speaking to Nature.com, Zaida Arteta, secretary of the Medical Union of Uruguay, said: “It’s not over yet, we still have dozens of serious cases and expect more deaths. But the vaccine roll-out is one of Uruguay’s strengths. They are efficacious, and we are vaccinating very well and quickly. I hope the trend continues.”
Chile has been hit hard by the pandemic, with 1.62 million cases and over 35,000 related deaths since it began. In response the government imposed a strict lockdown between March and November 2020 which drove infections down. In February 2021 it began administering vaccines, and within eight weeks more than a third of the population had received a first dose.
Currently 64% of the population have received two doses, however Chile is battling surges after restrictions were relaxed and Chileans were given special holiday permits to travel freely around the country during the summer months.
In June the capital city of Santiago went into another lockdown, but there are positive signs - the daily average rate of infections has dropped from 7,200 to 1,100 in the space of a month.
Before Bhutan's announcement, Israel had the fastest vaccine rollout in the world. The country's efforts to tackle COVID-19 have been labelled among the most efficient, thanks to a combination of population data and a campaign to encourage vaccine take-up driven by a mixture of text messaging and emails as well as outreach by ultraorthodox rabbis and leaders in Arab communities.
To date 62% of the population have received two doses of the vaccine, however like many other regions around the world new variants are surging. In June the requirement to wear a facemask indoors was re-introduced after a rise in cases.
A third booster vaccine is now being introduced for people over the age of 60 and those with weakened immune systems. The Pfizer booster vaccine will be given to people who received their second dose at least five months ago.