MedTech Europe, the European trade association for the medical technology industry, calls on the European Commission and EU Member States to remove any barrier undermining the industry’s capacity to help manage the current unprecedented public health emergency.
The ongoing outbreak of COVID-19, a major worldwide public health emergency, continues to cause a rising number of cases around the globe every day. Health authorities agree that in order to contain COVID-19 it is essential to rapidly identify those who are infected, to ensure that healthcare professionals can work safely, and that quality care is available to all those who need it.
Medical technology plays a critical role in each of these steps, particularly through three key categories of health products:
• New specific diagnostic tests
• Personal protective equipment (PPE) such as face masks, gloves, googles, protective suits, and
• Respiratory support equipment
“The medical technology industry has geared up its capacity to a maximum, and is fully committed to bring to healthcare professionals, patients and Member States all the support they need to contain and combat the virus,” underlines Serge Bernasconi, CEO of MedTech Europe. “We call on the EU and national health authorities to rapidly address both the challenge of availability of reliable IVD tests and any national decision which interferes with the access of PPE in Europe by preserving the spirit of the EU Internal Market. We also encourage authorities to actively involve the industry, manufacturers and their trade bodies alike, in the management of this crisis to jointly define practical and feasible solutions.”
First, rapid and accurate diagnostic tests are essential for two purposes: to identify individuals who are affected by the virus, and to properly understand how COVID-19 is spreading in order to establish an effective healthcare response strategy. Therefore, to be able to scale up testing of the population, CE marked COVID-19 tests will have to be made available to Member States in greater quantities.
So far, some 28 in vitro diagnostic tests have been CE-marked, mostly developed outside of Europe and not widely available in the EU. Manufacturers with the capacity to provide COVID-19 tests in sufficient volume and with matching instruments installed across the EU are now working towards compliance with the EU regulatory framework. We urge the EU Commission and the Member States to support those efforts by taking a harmonised approach to accelerate widespread access to reliable and high-quality tests.
Moreover, the role of healthcare professionals in combating COVID-19 is critical, and it is imperative that they can carry out their duties safely. In practice, this means that personal protective equipment (PPE) such as masks, gowns, goggles and gloves need to be made widely available to healthcare professionals. The medical technology industry, who produces and distributes PPEs, has geared up the production to amaximum capacity. It is committed to collaborate and support authorities in prioritising access to personal protective equipment to those at the forefront of diagnosing and treating COVID-19 patients.
However, several Member States, like Germany and France, have reacted to the outbreak unilaterally by requisitioning protective equipment or putting in place export bans. Such measures are counterproductive as they can create acute shortages in other parts of Europe. This prevents a more European approach to contain the spread of the virus and undermines equal access to needed equipment across the Member States.
The medical technology industry reaffirms its full commitment to support authorities in the management of the crisis. Furthermore, we call on the Commission and the Member States to support the companies’ efforts by taking a harmonised approach to accelerate widespread access to reliable and high-quality tests. We also urge the European Commission and the Member States to correct any unilateral decision and bring back the European spirit of access to needed healthcare solutions for all as quickly as possible. Finally, we encourage the competent authorities to work with industry to jointly define further needed practical and feasible solutions.
About MedTech Europe
MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute and supply health-related technologies, services and solutions.
For more information, visit www.medtecheurope.org