Oct 2, 2020

Low income countries to get millions of $5 Covid tests

covid-19
covid test
covid rapid testing
Leila Hawkins
4 min
Low income countries to get millions of $5 Covid tests
A well coordinated global effort is making millions of rapid Covid tests available to stop the spread of the virus...

This week it was announced that 120 million rapid diagnostic Covid tests will be available to some of the world's poorer countries at a low cost. It represents the biggest roll-out of rapid tests so far, and is the result of a major international cooperation. This is the story of what made it possible.

"It is proof that by working together at a massive global scale, we can develop and deploy a vital new tool to help contain and fight the pandemic. This is not just a new test – it’s the money and the deployment plan to get it to where it’s needed, fast. This is the power of global collaboration.” These were the words of Peter Sands, Executive Director of the Global Fund, commenting on the news that millions of Covid tests will be made available to some of the poorest countries in the world. 

Initially the tests will be available to 20 countries in Africa, starting this month. With results provided in just 15–30 minutes, these are faster than other tests, and will only cost $5, although it is expected this price will decrease over time. 

The tests are the creation of Abbott Laboratories, a US-based company with manufacturing sites around the world, and SD Biosensor, based in the Republic of Korea, who have sites in India, Indonesia and China. 

Their work began in February 2020, as soon as genetic sequencing for the virus was released. Compared to molecular PCR tests which can identify the genetic DNA of the virus, and antibody tests that can pick up antibodies from a past infection, these antigen rapid diagnostic tests (Ag RDTs) detect active infection by identifying antigen proteins of the virus. They are easy to use and portable, having a similar appearance to a pregnancy test. 

"They can be used in a variety of settings, but may be particularly useful where resources are limited or in settings without sophisticated laboratory infrastructure to ensure more people would get access to testing services" explains Robert Matiru, Director of Programme Management at Unitaid. 

A partner of the World Health Organisation (WHO), Unitaid will work with Africa Centres for Disease Control and Prevention (CDC) to start rolling out the tests throughout the continent. Organisations active in the Covid response in these countries will work with them to bolster testing and tracing efforts to minimise the spread of the disease. 

"Compared to the current laboratory-based molecular (PCR) tests available for Covid-19, the speed and affordability of Ag RDTs is a game-changer in enabling countries to increase their speed and volume of testing, contact-tracing, treatment and isolation, particularly for under-resourced settings" Robert says. 

It took a total of eight months for the tests to be ready for the market. To get to this stage they had to meet a robust set of criteria. "The product must satisfy the WHO’s requirements for Emergency Use Listing, which includes target product profile specifications to inform the suitability, technical performance, quality and safety of the test product" Robert explains. "Once approved, these tests must be registered for use by regulatory authorities in lower-and middle-income countries."

Robert says that existing technology from efforts to combat other infectious diseases such as Ebola and malaria helped accelerate the development of the tests. Developers are also investing in things like automation, to be able to meet increased demand over an unknown time period. "Unitaid and FIND are tracking the product pipeline and assessing a portfolio of Ag RDT manufacturers that may benefit from support to optimise raw material supply and production capacity, and improve technology to improve usability" he says. "The pipeline appears to be robust, and in addition to Abbott Laboratories and SD Biosensor, there are several other promising technologies at various stages of development or review." 

The global effort has been hailed as a huge milestone in tackling the pandemic, and an example of successful international cooperation. "The collaboration on research and development, commercialisation, market readiness, and in-country preparedness for Ag RDTs during this pandemic has been exemplary and unprecedented" Robert says. 

Partners on the project include Unitaid, The Foundation for Innovative New Diagnostics (FIND), The Global Fund, The World Health Organization, The Bill and Melinda Gates Foundation, The Clinton Health Access Initiative, and the Africa Centres for Disease Control among many others. 

"A set of agreements have been made between the partners under the Access to Covid-19 Tools Accelerator (ACT-A) Diagnostic Pillar to ensure that all countries have fair access to new tests for Covid-19. The incredible speed with which this package of initiatives has come together is a testament to the impact of the partners working together under the ACT-A initiative." 

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Jun 20, 2021

Medical device companies: how to prepare for Brexit

medicaldevices
supplychain
Brexit
Compliance
Ed Ball
6 min
Ed Ball, Senior Associate at RQM+ , explains how medical device companies can prepare for post-Brexit compliance

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. 

Rigorous Planning
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.

Authorised Representatives
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.

Clinical Investigations
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.

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