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We are all navigating unchartered waters as business and society faces up to the impact of COVID-19. We very much hope you and your loved ones remain in good health.
Please be assured that Fieldfisher is continuing to work with clients to navigate COVID-19 related issues and on business as usual needs. Do get in touch with us if you would like to chat anything through.
Having issued a recommendation on 13 March 2020 aimed at speeding up time to market for PPE and medical devices used by health care professionals caring for patients with COVID-19, the EU Commission has introduced an Implementing Regulation setting out emergency export controls on PPE. The categories of PPE items subject to control are listed in Annex I of the Regulation and include masks, gloves, gowns and eyewear. These controls, which came into force on 16 March 2020 and will apply for a period of six weeks, are intended to assist EU health authorities in responding to the Covid-19 outbreak by protecting the supplies of PPE within the EU. Irish businesses wishing to export items on the list outside the EU must apply to the Department of Business, Enterprise and Innovation for authorisation. The EU Commission has also issued guidelines in relation to the practical implementation of the Regulation.
The Health Products Regulatory Authority ("the HPRA") note that although the new Regulation does not restrict the free circulation of PPE within the single market, prior authorisation will be required in order to export items on the list to countries outside the EU. A number of countries are exempt from this Regulation including the UK (for the duration of the Brexit Transition Period), Norway, Iceland, Lichtenstein, Switzerland, Andorra, the Faroe Islands, San Marino, the Vatican City and the countries and territories listed in Annex II of the Treaty on the Functioning of the European Union.
In Ireland, the Health and Safety Authority (HSA) is responsible for respiratory PPE i.e. equipment such as face masks used to protect the user from inhalation of hazardous substances. The HPRA is responsible for medical devices however, and surgical face masks are classified as medical devices where they are intended to be used in a medical, surgical or dental setting. Surgical masks that qualify as medical devices should be CE marked in accordance with the Medical Devices Directive (93/42/EEC). The HPRA has developed a process for the urgent assessment of applications to use non-CE marked medical devices specifically addressed to regulatory derogations for the management of the COVID-19 pandemic. The HPRA has stated that it will conduct an initial review of such submission and will work with the consultant and manufacturer applicant to complete the review as quickly as possible.