Reed Smith Client Alerts

As the COVID-19 outbreak continues to expand globally, the supply chain for COVID-19-specific medical devices and personal protective equipment (PPE) will continue to be stressed as demand exceeds available supplies.

MedTech Europe – the European trade association representing the medical technology industries – issued a statement on 11 March calling on the EU and the Member States’ health authorities to ensure access to PPE in light of the coronavirus (as well as to diagnostic tests and respiratory support equipment).1

The European Commission has now issued a recommendation, on 13 March 2020, which aims at speeding up time to market for PPE and medical devices used by health care professionals (HCPs) caring for patients with COVID-19 disease.2

作者: Wim Vandenberghe

surgical mask

Before turning to the recommendation, we first look at the regulatory status of this medical equipment and the normal approval process to start selling it across the EU.

Medical devices vs PPE

PPE ranges from firefighters’ fire retardant jackets to safety helmets and footwear. PPE is also widely used in the health care sector and includes gloves, aprons, goggles, face visors and respirator masks.

Health care PPE is subject to the EU PPE Regulation3 and/or the EU Medical Device Regulation (MDR).4

Some products may appear to have a medical purpose, but in fact are designed to protect the user. Such products are usually considered to be PPE rather than medical devices. This will depend upon the intended purpose for the individual product concerned. For example, ionising radiation protective clothing, which is typically intended for the protection of health care professionals, will be PPE. Conversely, surgical masks (for use in an operating theatre) are medical devices as they are intended to protect the patient rather than the user. In the case of examination gloves, both the EU PPE Regulation and EU MDR could be applicable as they are intended typically by the manufacturer to be used to protect the patient (medical purpose and thus in scope of the EU MDR) and also to protect the health care professional (protection purpose and thus in scope of the EU PPE Regulation).