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PPE to the Rescue! Requirements – EU and USA – Elexes
Elexes Medical Consulting

A lot of companies are being asked by their government to make PPE to help during COVID crisis, and many are choosing to get into this area to be able to compensate for the revenue decline in other areas. While this is a great opportunity to help during the pandemic and support the business, it is equally important to know the regulatory requirements around the PPE, so when the companies do this, they do it right without having to fear any potential repercussions.

Personal Protection Equipment (PPE), includes protective clothing, helmets, gloves, face shields, goggles, surgical masks, respirators, and other equipment designed to protect the wearer from injury or help prevent wearer exposure to infection or illness. 

Important note

It is important to note that the types of regulations that apply to PPE depend on what claims are made for these products and what they are intended to do. 

E.g., personal protective equipment for general purpose or industrial use (that is, products that are not intended for use to prevent disease or illness) are not regulated by the FDA.

For these types of products, entry information should not be transmitted to the FDA. At the time of entry for these products, Importers should transmit entry information to US Customs and Border Protection (CBP) using an appropriate HTS code with no FD Flag; or using an appropriate HTS code with an FD1 flag and should do a ‘disclaim’ for FDA.

It is important that the labeling is truthful and accurate, as there can be major repercussions if it is not so. 

For EU, please note that the regulations and medical device requirements do not apply to the PPE that are: 

  • specifically designed for use by the armed forces or in the maintenance of law and order;
  • designed to be used for self-defence, with the exception of PPE intended for sporting activities;
  • designed for private use to protect against:
    • atmospheric conditions that are not of an extreme nature,
    • damp and water during dishwashing;
  • for exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States;
  • for head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds.

United States Food and Drug Administration (US FDA) 

Classification 

For every type of PPE like facial masks, gowns, etc. the classification will depend on the intended use of the product. A quick example on how FDA regulates each of these differently is shown below – 

Classification RegulationDevice TypeProduct codeClass
21 CFR 878.4040Conductive Shoe and Shoe coverBWPI (exempt)
21 CFR 878.4040Operating-Room ShoesFXWI (exempt)
21 CFR 878.4040Surgical Apparel AccessoryLYUI (exempt)
21 CFR 878.4040Non-surgical isolation gownsOEAI (exempt)
21 CFR 878.4040Surgical suitsFXOI (exempt)
21 CFR 878.4040Operating-Room Shoe coversFXPI (exempt)
21 CFR 878.4040Surgical helmetsFXZI (exempt)
21 CFR 878.4040Surgical dressFYEI (exempt)
21 CFR 878.4040Surgical capsFYFI (exempt)
21 CFR 878.4040Surgical gown/togaFYAII
21 CFR 878.4040Patient gownFYBII
21 CFR 878.4040Surgical isolation gownFYCII
21 CFR 878.4040Surgical hoodFXYII

Requirements 

  • Based on the product’s intended use, indications for use and technological characteristics, the applicable product code is determined and accordingly the classification and subsequently a requirement of 510(k) application or FDA registration and listing would be determined. 
  • Compliance with current Good Manufacturing Practice (cGMP) or Quality System Regulation (QSR) is mandatory for PPE and can be evaluated by the FDA in any inspection, as they see fit. The scope of the QSR is dependent only on the activities performed at the company as it relates to the product’s manufacturing, sales, distribution etc. 

European Union (EU) 

Classification 

Class I ns nm – Non-Sterile Non-Measuring. Assuming the device is non-sterile. 

Requirements 

  • Self declaration can be done for this device – a Notified Body (NB) is not needed to be involved 
  • The quality systems need to be in place and should be in compliance to ISO 13485:2016. This is voluntary but recommended for avoiding potential lawsuits etc. A certification body does not need to be involved right away, but seeking the certification would help in the long run. 
  • If you have an existing quality system as per the ISO 9001:2015 – Quality Management System, or something similar, many procedures or base systems can be leveraged from there and can be applied to the manufacturing assembly etc of PPE. 
  • You would need to have a European Authorized Representative in the EU to represent your PPE products and to be the point of contact for any questions etc from the Competent Authorities of the EU. 
  • There would need to be technical file, medical device file and some base documents around the product.

Questions to ask yourself as a Manufacturer 

  • What operations are you going to be performing for the PPE like manufacturing, design, distribution, sales, etc. at your company?
  • Are you planning to manufacture the product yourself or would you private label?
  • What are the indications for use of each of the products within the PPE that you intend to market into the EU and US markets? 
  • What are the technological characteristics of your PPE like sterile or non sterile, etc.?
  • Are you an importer, a domestic company, or an exporter w.r.t. the target market – this would govern a lot of requirements that apply to you? 

For any questions, please feel free to contact jennifer@elexes.com

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