Newsflash | Europe/US | Lack of personal protective equipment a great difficulty in fight against Coronavirus
Europe/US
Lack of personal protective equipment a great difficulty in fight against Coronavirus
The outbreak of the coronavirus globally has resulted in the necessity for national authorities to adapt legislation in order to facilitate an increase in the production and distribution capacity of personal protective equipment and an acceleration of product approval, as a result of the lack of PPE available globally.
In Europe, the production of masks and other personal protective equipment (PPE), leave-on hand cleaners and hand disinfectants and 3D printing to facilitate the development of these products, in have become a priority to support the fight against coronavirus.
For this reason, the European Commission has made available the following documents with the aim of supporting manufacturers and market surveillance authorities to ensure these products comply with necessary safety standards and are effective.
On 30th March 2020, the European Commission published the following guidance:
- Conformity assessment procedures for protective equipment (Guidance for manufactures) – This guidance details applicable EU legal frameworks and steps that manufacturers need to take to place their products on the EU market
- Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)
- Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
The following information related to medical devices and personal protective equipment are also of note:
- Recommendation C/2020/1712 (16/03/2020):
Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
With the aim to facilitate the rapid uptake of new products on the EU market
- European standards for medical supplies made freely available to facilitate increase of production (20/03/2020). The standards are available for free download from the websites of CEN national members
For further information about medical devices, please consult the European Commission’s website here. For further information about personal protective equipment, please consult the European Commission’s website here.
In the US, The U.S. Food and Drug Administration (FDA) published the following statement on 24th March 2020:
With the aim of providing instructions to facilitate the import process of products related to the Coronavirus Disease-2019 (COVID-19) public health emergency.
The FDA‘s website has a dedicated section with updated information about personal protective equipment for infection control and outlines specific information about:
- N95 Respirators and Surgical Masks (Face Masks)
- Medical Gloves
- Medical Gowns
- Questions About Personal Protective Equipment (PPE)
- FAQs on Shortages of Surgical Masks and Gowns
The agency is providing maximum flexibility to those seeking to bring PPE into the U.S and is ready and available to engage with importers to minimise disruptions during the importation process.
