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MDR Regulator CE marking Personal protective equipment (PPE)

Personal protective equipment (PPE)

Personal protective equipment is a device that protects its users from mechanical injuries of individual parts of the body. These products provide protection for the worker as well as protection against potential hazards.

What is a personal protective equipment?

Personal protective equipment (PPE) may include (in accordance with Regulation PPER 2016/425/EU):

  • measures designed and manufactured to be worn or held by a person to protect against one or more risks to that person’s health or safety,
  • exchangeable components of the abovementioned measures which are essential for their protective function;
  • systems for connection to the above mentioned agents, which are not worn or held by a person, are designed to connect these agents to an external device or to a stable anchorage point, are not intended to be permanently attached and do not require assembly work to be carried out before use;

What are the types of personal protective equipment?

In accordance with the provisions of the regulation, personal protective equipment is classified according to the category of hazard against which it is intended to protect. There are 3 hazard classes:

  • Class I, covering minimum risks,
  • Class II, covering hazards not listed in Class I and III,
  • Class III, covering hazards with very serious consequences, i.e. death or irreversible damage to health.

What requirements should personal protective equipment meet?

  1. They should be appropriate to the risk involved and not in themselves cause an increased risk,
  2. should correspond to the conditions of the job,
  3. should take into account ergonomic requirements as well as the health of the worker,
  4. should be properly adjusted to the user after the necessary adjustment.

How to put personal protective equipment on the EU market?

Before placing personal protective equipment on the market, the manufacturer should carry out conformity assessment procedures appropriate to the risk class. Certain classes are also subject to a conformity assessment carried out by an external notified body, which ends with a CE certificate.

Before placing on the market, the manufacturer should

  • provide an EU declaration of conformity,
  • implement internal production control to ensure compliance with the Regulation,
  • prepare technical documentation for the products,
  • attach instructions and other information for consumers and other end-users.

Our experts will provide a comprehensive service for placing personal protective equipment on the EU market.

Personal protective equipment and COVID-19

Personal protective equipment is designed to protect against the risks associated with COVID-19. These products include: disposable and reusable face masks providing protection against particle hazards, disposable and reusable overalls, gloves and safety goggles which serve to prevent and protect against harmful biological agents such as viruses.

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