Impact of COVID-19 on the Global Medical Device & Accessories Market
Whether it is ventilators needed in an emergency and intensive care facilities, personal protective equipment (PPE), or in-vitro diagnostic (IVD) kits to detect viruses, the medical device market is in the center of efforts to fight the COVID-19 outbreak. It has become imperious for medical device manufacturing companies to be able to handle the sudden increase in demand for equipment and perform further research. Moreover, the COVID-19 pandemic is increasing the demand for medical services, causing upward modifications to the global healthcare expenditure forecasts. Every country is countering the outbreak in different manners due to different in healthcare systems, government response, and cultural norms, including propensity to self-isolate.
Furthermore, PPE includes medical equipment such as masks, gloves, protective goggles, and protective clothing. Products that fall under this category require lengthy conformity valuation before their medical device market entry. In an attempt to adapt the supply of these products to the rising market demand, the EU has now sought to simplify the market entry process for PPE providers to a substantial extent. They have also requested market surveillance authorities and notified bodies to take all available measures to provide immediate access to PPE and medical devices for healthcare professionals during the prevailing healthcare crisis. As such, medical device companies in Germany must carefully assess and organize with the competent supervisory establishments and notified bodies to regulate whether their products are eligible for healthcare market access facilitation in line with the commission’s recommendation.
Moreover, on 25th March 2020, the European Commission declared that it intended to postpone the Medical Device Regulation (MDR) application date for one year from May 2020 to May 2021. The decision was taken with patient health and safety as a guiding principle. This decision relieved the pressure on national authorities, including notified bodies and manufacturers, allowing them to focus on crucial priorities relating to fighting the COVID-19 pandemic.
Furthermore, the notified bodies such as organizations that have been established by an EU member state to ensure that certain products confirm with the necessary technical requirements before they are sold in the EU market have already closed or limited their activities. Authorities have been affected similarly as there are no longer on-site audits. Companies and production sites must adapt to the pandemic as suppliers are shutting down production or are incapable of manufacturing enough products to meet the increasing demand for medical devices and related accessories.
The COVID-19 outbreak has also affected preparations for the upcoming EU medical device regulations as scientists and engineers that were working on the new MDR framework are switching to COVID-19-related research. Many research institutions and industry are building up additional research and production capacities to meet the increasing demands due to COVID-19.
Hence, to meet the high demand for medical devices in the EU, the European Commission has, through its EU Regulation of 14th March 2020, temporarily made the export of certain products subject to authorization. An export authorization is approved only in individual cases. These newly introduced export limitations are difficult for companies that are contracted to supply products covered by this regulation to third countries. Exports of medical protective equipment from the EU to the European Free Trade Association states such as Switzerland, Liechtenstein, Norway, and Iceland are exempted from the export authorization requirements. Companies must consider applying an export license and, if not, the legal or commercial opportunities that deal with the export ban and existing business relations with their partners.
However, due to the pandemic, the medical device industry has been under great pressure to deliver and innovate. The European Commission has been proactive by making decisions to help the industry and the population to help fight the virus.