Both the European and the United States regulatory authorities have issued multiple guidances in response to the COVID-19 emergency, in order to ease the burden on the healthcare system and facilitate the production and import of needed devices during the crisis while at the same time, ensuring the safety of patients and users and providing adequate oversight of product approval procedures.

This article describes the different approaches taken in Europe and the US to react and adapt quickly to the shortage of respirators and ventilators during this pandemic. The underlying principle of all authorities is to provide maximum regulatory flexibility and helping to increase the ventilator inventory so that COVID patients have access to lifesaving devices.

Europe. New MDCG guideline

In regards to Europe, the European Commission’s Medical Device Coordination Group (MDCG) posted five new guidances last week, one being requirements for ventilators. The MDCG guideline 2020-9 for Ventilators, describes different regulatory options for bringing devices to market in order to enable the rapid entry of much-needed devices amid the COVID-19 pandemic. These options range from supplying parts or finished devices to medical device manufacturers and companies looking to place new ventilators on the market.

The guidance also explains that the recent amendment to delay the application of the Medical Devices Regulation (MDR), allows European Member States to adopt derogations for authorizing the marketing of devices that have not completed a conformity assessment, i.e. without a CE mark. With the medical devices sector being highly regulated, the scenarios presented in the guidance are applicable to increase supply in the short term while guaranteeing patient safety.

ISO Standards freely available

As part of the Covid-19 response, the International Standardization organization has made the standards for ventilators freely available. A variety of standards can be consulted, including all standards of the ISO 10651 series for lung ventilators and other standards for anaesthetic and respiratory equipment.

US FDA Guidelines for Ventilators

In the United States, the FDA activated a special pathway, the Emergency Use Authorization (EUA), to allow for the emergency use in health care settings of certain ventilators, ventilator tubing connectors, and ventilator accessories that the FDA determines to meet specified criteria for safety, performance, and labeling. The FDA Enforcement Policy provides information of the procedures to follow to obtain the authorization.

In order to support greater availability of devices for patients in need of ventilatory support during the COVID-19 emergency, the FDA is interested in interacting with manufacturers of ventilatory support devices that are not currently legally marketed in the U.S. as well as manufacturers who have not previously been involved in medical device manufacturing to increase supply of these devices. This EUA hopes to demonstrate the U.S. ability to react and adapt quickly during this pandemic by providing maximum regulatory flexibility and helping to increase the U.S. ventilator inventory, to provide ill patients with life saving devices, while still providing appropriate FDA oversight.

The list of FDA Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories as of April 28, 2020 can be found here.

AAMI EMERGENCY GUIDELINES

The AAMI COVID-19 Response Team, made up of manufacturers, clinicians and FDA representatives, is working to provide emergency guidance to the healthcare community in response to the coronavirus pandemic. AAMI has posted guidances on Emergency Use Ventilators and Resuscitator Systems, including design guidance and end-user disclosures. Additional guidance will be posted here as it is developed.

EU vs. US: Head to Head Comparison

Both the focus of the European model and US model to address the emergency, is to increase the flexibility for manufacturers and aim for less stringent guidelines in order to generate the facilitation and production of much needed ventilators. However, the EU model seems to have a more structured and organized process for facilitating production in regards to their derogation plan from other member states to authorize the marketing of the devices. The FDA is encouraging modified ventilators and manufacturers to apply during this time, but will be going through this EUA on a case-by-case basis. In either case, swift action is being taken to ease burdens on the health care system during this pandemic and close the gap during this time of crisis.

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