The elimination of barriers and the introduction of free movement of goods, services, and people across the Member States – the so-called Single Market – has granted, among others, larger supply sources, more diversified sources of funding, and generally, a more dynamic business environment. The Annual Single Market Report, published in February 2022, gives an overview on some of the most important challenges faced during the pandemic in the EU Single Market. From the impact on the economy to new measures to increase the Market’s resilience, this report focuses on what the European Union did and needs to do in such emergency situations.
The pandemic has shown that disruptions in the Single Market can occur and cause enormous consequences. The outbreak of the COVID-19 pandemic has led to recession and severe economic downturns, showing the vulnerabilities of the Single Market system. Border closures and breaks in integrated value chains have deeply affected the trade in the European Union, especially during the first months of the pandemic. Indeed, intra-EU trade was initially hit even harder than extra-EU trade. In this environment of uncertainty, the flow of goods from extra-EU countries helped to keep a balance between the demand and supply in the EU Member States and to avoid a more severe shortage of goods.
Unquestionably, supply and demand imbalances have emerged in various markets during the pandemic. The sudden shortage of certain medical materials and personal protective equipment (PPE) have been some of the most discussed challenges in global supply chains since the beginning of the pandemic. In this turbulent context, the necessity to reinforce the Single Market and to boost its resilience in such situations arose.
How the EU faced shortage of personal protective and medical equipment
Considering the shortage of personal protective equipment (PPE) and medical supplies during 2020, the European Commission took several initiatives to address this issue. The sudden increase in the demand for good-quality protection equipment, such as medical suits, masks, gloves, etc., led countries to suffer a consistent shortage of materials. Even China, which holds half of the global production of such products, experienced a lack of PPE. To face this matter, the European Commission took various measures, which included:
- Cooperation with Third Countries to ensure the free flow of goods and to avoid a decrease of production of essential goods to fight the pandemic;
- Monitoring of supply through questionnaires;
- Simplifying the conformity assessment procedures for PPE;
- Call on Notified Bodies to prioritize the assessment of medical equipment;
- Establishment of the Clearing House for medical equipment to share information with Member State representatives on the demand and supply of medical equipment.
Especially, the creation of the Clearing House has been an important prompt step taken to track the availability of medical supplies needed to fight the virus. It played a role not only in enabling a fast and easy way to share information, but also in the prevention of even more severe shortages of medical products, devices, testing, and similar. However, the European Union immediately identified also the necessity to speed up the procedures to place new medical equipment on the market. For instance, the call on Notified Bodies to prioritize certain products allowed, in the peak of the sanitary emergency, to put some products to fight the pandemic quickly on the market. While for PPE a Notified Body may beappointed (mandatory for category II and III), medical equipment is normally assessed and certified by a notified body (except simple Class I).
The 2020 Single Market Enforcement Action Plan includes other measures as well. Before February 2022, the EU has implemented following selected actions:
- Market Enforcement Action Plan;
- Training and exchange of practices for national judges and practitioners (EUDAMED);
- EU Product Compliance Network;
- Strengthening the fight against counterfeit and illegal products;
- Improving access to information on rules and requirements for users;
- Training and exchange of practices for national judges and practitioners.
Diversification of sourcing as prevention against shortages
The pandemic has shown us that more diversified and interconnected economies have survived the pandemic better than economies highly reliant on one or very few sectors. This also applies to countries – but also manufacturers – whose supplies are highly dependent on one or very few sources. Therefore, the European Union, as stated in the Updated Industrial Strategy of May 2021, identified the necessity to make the market more resilient by addressing strategic dependencies. Trade diversification and cooperation with extra-EU countries are key measures to adopt to face such sudden shortages and emergencies. In this sense, EU actions to boost resilience in the post-pandemic market include, among many others, putting in place the enabling regulatory environment, diversifying trade, creating new trade partnerships, promoting diversification of sourcing, and mobilizing EU funding and private investments.
Are you a non-EU manufacturer wishing to sell your medical equipment or PPE on the EU market? We will gladly assist you to reach the full compliance of your product!
Expert Consultant, Publications department
European Commission. (2022). Annual Single Market Report 2022. Retrieved on 03/03/2022 from: https://ec.europa.eu/docsroom/documents/48877/attachments/2/translations/en/renditions/native.
European Commission. (2020). COVID-19 Clearing House for medical equipment. https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/emergency-support-instru.ment/covid-19-clearing-house-medical-equipment_en.