As the number of cases of COVID-19 (coronavirus) grows around the world, so too have questions regarding the potential impact of the pandemic on the medical device industry. At this time, projections of a deleterious impact on the health care system and supply of medical devices are becoming more of a reality. This is a European Supplement to two U.S. focused client alerts that provide medical device manufacturers with resources and information regarding how to address an evolving pandemic in real time. This European Supplement discusses action taken by individual member states and the implications to medical devices in the EU.
We continue to monitor the evolving significance of the coronavirus to the medical device global supply chain with close attention to the actions of regulatory authorities. This article details the actions taken by EU individual member states and the implications for medical devices in the EU. Part I of this series covers the regulatory and business options available for companies to bring new (unapproved) products to market that are essential to address the public health need under the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorizations (EUAs). Part II describes how medical device companies regulated by FDA can plan for shortages and other challenges to their supply chains for both essential and non-essential devices.
Actions by individual EU Member States
The French authorities have adopted Decree No 190/2020 of 3 March 2020 permitting seizure of all available medical masks in the country. The Decree instructs that all stocks of Filtering Face Piece 2 (FFP2) type respiratory protection masks, as well as all stocks of anti-projection masks produced between the publication of the Decree and 31 May 2020, be requisitioned. This step is despite the fact that the EU crisis management Commissioner, Janez Lenarčič, has advised that nations put solidarity above national interests. In light of the fact that medical masks can be indispensable in the manufacturing process of some medical devices, this decision could affect the production, and consequently the supply chain, of medical devices.
Germany has established a National Pandemic Plan according to which protective equipment supplies will be stored by the federal government and made available at the local level. An export ban on protective equipment and certain health care products has also been introduced by a joint crisis committee made up of federal ministries of the interior and health.
The German medical devices industry immediately identified problems with the National Pandemic Plan, stressing that production networks and supply chains are international. However, a similar plan has been adopted by Czech Republic. Lithuania and Italy are considering adoption of similar steps to protect public health. These measures could affect supply networks throughout the EU.
In Italy IMQ, a notified body based in Milan and one of 11 notified bodies designated under the Medical Devices Regulation No 745/2017 (MDR), has been quarantined. Furthermore, all nine of Italy’s notified bodies designated under the existing EU Medical Devices Directive are located in lockdown zones. It is expected that the closing down of Italian notified bodies due to coronavirus will impact the plans of medical device manufacturers by causing significant delays regarding renewal of CE Certificates of Conformity issued under the Medical devices Directive as well as MDR conformity assessment procedures.
Resultant difficulties in the flow of information between notified bodies and medical device companies may impose strain on the industry in light of the upcoming entry into application of the MDR on 26 May 2020.
According to the UK Department of Health and Social Care, the coronavirus has evolved from being a China supply chain issue to becoming a global issue. The Department also stresses the fact that coronavirus is expected to come in waves. It is, therefore, important in the Department’s view that stakeholders prepare for medium and long-term shortages within supply chains for medical devices, even though the short-term effects are expected to be modest.
The Department of Health and Social Care is also conducting supply chain assessments to develop a clear picture where vulnerabilities lie in the devices supply chain. This means that alternative supply sources will need to be sought in cases where the chain breaks in high-risk countries like China, Italy, or any other affected region.
Maritime and transport
The International Chamber of Shipping has estimated that the coronavirus is costing the industry $350 million a week in lost revenues. Global supply chains continue to suffer, and issues remain around the quarantining of ships and ports. Port calls to China have dropped by over 30% since the beginning of 2020.
In Europe, Rotterdam and Hamburg have been hit the hardest with regard to containers from Asia. There has been an estimated 0.7% reduction in global traffic in the first quarter of 2020. According to one estimate in the port of Rotterdam there has been a reduction of 1% in global traffic, or 150,000 containers. It is also expected that the number of trains coming from China to the EU will also decline significantly. These developments in maritime and transportation may cause significant strain to the medical devices supply chains.