16.01.2021 Who are the regulatory bodies for PPE and medical devices?
Who are the regulatory bodies for personal protective equipment and medical devices in the US and EU and what are their functions?
Personal Protective Equipment (PPE) has become a must for stepping outside in the Covid-19 crisis to avoid getting contaminated. This has substantially increased global demand for PPE products. However, attention to PPE products has also brought much confusion. Therefore, Cruso Hygiene AG aims to acquaint the public with the updated and most important topics related to PPE. This article analyzes the different controlling bodies for PPE and medical devices in the US and the EU.
Regulations of PPE and Medical devices are primarily concerned to ensure high quality, safety and effectiveness of usage products for employees protection and patients. However, PPE regulations are a controversial topic in both the US and the EU. The complexity starts with defining and classifying different PPE products. It is crucial to understand that there are two categories of PPE: products with intended use of medical-purpose and products with intended use of non-medical purposes. Different controlling bodies are responsible for the assessment of PPE and medical devices in the US and the EU.
Regulations in the United States
All PPE that is intended for use as a medical device, has to follow the Food and Drug Administration (FDA) regulations and meet all the standards for protection in the US. The FDA is a centralized agency that is responsible for monitoring adverse events and other problems mainly related to medical devices and other medical products. A manufacturer, which is willing to market medical devices in the US, must obtain the FDA’s prior approval or clearance first. Also, one of the crucial FDA’s functions is to ensure the proper use of medical goods and thus the health & safety of patients. There are several branches, which works on behalf of the FDA, responsible for overseeing the manufacturing, performance and safety of medical devices.
- Center for Devices and Radiological Health (CDRH) - responsible for medical device premarket review.
- Center for Biologics Evaluation and Research (CBER) - responsible for regulating devices associated with blood collection and processing procedures, cellular products and tissues.
Thus, the FDA supervises all aspects of medical goods regulation, including approval and post-market surveillance.
General-purpose or industrial use PPE, as masks, gloves and respirators, that are not intended to prevent disease or illness, are not regulated by the FDA. Instead, different government agencies provide the guidelines for use of PPE.
- The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) PPE is addressed in specific OSHA standards. OSHA is responsible for setting the requirements for employers to provide appropriate PPE for their workers who might have been exposed to blood or other infectious materials.
- PPE requires to meet standards developed by the American National Standards Institute (ANSI).
- National Institute for Occupational Safety and Health (NIOSH) as part of the Center of Disease and Control (CDC) is a non-regulatory agency responsible for the certification and approval of respiratory protection devices, intended for occupational use. NIOSH guidelines are often used as a pattern for other agencies that are responsible for the enforcement of occupational safety and health regulations.
Regulations in the European Union
The regulatory structure in the EU is different from that in the US. The counterpart body for FDA in the EU:
- European Medicines Agency (EMA) - a decentralized agency, which is responsible for the scientific evaluation of applications for authorization to market medical products in Europe. EMA evaluates the marketing authorization applications in terms of quality, efficiency and safety. Applies centralized procedures to address Medical devices in terms of safety and performance.
- The medical device approval process is regulated by Notified Bodies - private companies that carry out conformity assessment procedures, involving an audit of the quality system and review of technical documentation, stated in applicable legislation. The EU certifies the Notified Bodies, which engage in contracts with manufacturers to regulate device approval and grant the Conformité Européenne (CE) mark, which allows the device to be marketed in all EU countries. However, not all medical devices require the services of a Notified Body. For example, Class I medical devices that are non-sterile and without measuring function, don’t require the involvement of Notified Body. Instead, the manufacturers self-certify by applying the CE mark. On the other hand, if the Class I device has a measuring capacity or is supplied in sterile condition, the manufacturer has to apply to the Notified Body. For the devices that fall under Class IIa (low to medium fisk), Class IIb (medium to high risk) and Class III (high risk) the approval of Notified body is required.
- "National Competent Authorities" which are government agencies that conduct postmarket surveillance of safety. These agencies are authorized to act on behalf of the government of the member state to ensure the transposition and application of the Medical Device Directives and requirements to National Law.
- The main legal European framework for Medical devices is issued by the European Parliament and the Council. The latest directive has been adopted in April 2017 of Regulation (EU) 2017/745 on Medical Devices (MDR) on the clinical investigation and sale of medical devices for human use.
Legislation for Personal protection equipment (Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016), which covers the design, manufacture and marketing of personal protective equipment in the EU7. CE marking signifies that PPE products sold in the European Economic Area (EEA) have been evaluated and meet the common standards according to the regulation (EU) 2016/425.
Consequently, even though controlling bodies for medical products in the US and the EU share similar objectives, including promoting and protecting public health, there is a significant difference between them: one is more regulatory, the other - reviewing.
- The FDA is a centralized regulatory body, which supervises and evaluates the development of medical products in a single country and conducts these processes by the FDA’s own staff, while EMA is a decentralized agency, which manages the process in many member countries.
- In the EU, postmarket surveillance of medical product safety is conducted by the national agencies of the member states and the conformity assessment process is conducted by Notified Bodies. PPE products without an intended medical purpose in the US are monitored by the US Department of Labor's OSHA and NIOSH as part of CDC.
- In the EU, to be able to place PPE and Medical devices in the market, it must be CE-marked with the EC or the EU declaration of conformity signed and issued by the manufacturer.