Path to EU Market Entry: Compliance
There are defined three categories of equipment based on the risk against which the equipment is intended to protect users.
Category I – Minimal risk
In this category, the PPE is designed to protect people from minimal risks:
a) Superficial mechanical injury;
b) Contact with cleaning materials of weak action or prolonged contact with water;
c) Contact with hot surfaces not exceeding 50°C;
d) Damage to the eyes due to exposure to sunlight (other than during observation of the sun);
e) Atmospheric conditions that are not of an extreme nature.
Category II – Intermediate Risk
This category covers risks other than those defined by neither Category I nor Category III.
Category III – Serious Risk
The PPE designed to protect people from risks that may cause very serious consequences such as death or irreversible damage to health:
- Substances and mixtures which are hazardous to health (carcinogenic, mutagenic, reprotoxic, toxic, irritant or sensitizing)
- Atmospheres with oxygen deficiency
- Ionising radiation
- High-temperature environments, the effects of which are comparable to those of an air temperature of at least 100°C
- Low-temperature environments, the effects of which are comparable to those of an air temperature of -50°C or less
- Falling from a height
- Electric shock and live working
- Harmful biological agents
- Cuts by hand-held chain-saws
- High-pressure jets
- Bullet wounds or knife stabs
- Harmful noise
Each risk category of PPE must comply with clearly defined conformity assessment modules prior to being placed on the market.
PPE covered by categories II and III requires the product to be certified by a Notified Body (NB). The Notified Body will issue an EU type-examination certificate following successful evaluation of a manufacturer’s technical file and independent testing report.
PPE shall meet certain health and safety requirements (Annex II) to not endanger person and properties as those:
- general requirements applicable to all PPE, such as ergonomics, absence of inherent risks and other nuisance factor and manufacturer’s instructions and information
- requirements specific to certain types of PPE, such as PPE subject to ageing or PPE for intervention in very dangerous situations
- requirements specific to particular risks, such as protection against mechanical impact or in liquids or against ionising and non-ionising radiation.
PPE which is in conformity with harmonized standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by those standards or parts thereof.
The manufacturer compiles the technical documentation, which makes it possible to assess whether the PPE equipment complies with the requirements of the Regulation. It contains at least the elements set out in the Annex III.
The non-compliance with the Regulation’s requirements will result in the removal of the equipment from the market and the revoke of the CE marking affixed on it.
- The Regulation: PPE Regulation (EU) 2016/425
- The Transition to the New Regulation (EU) 2016/425
- Personal Protective Equipment Directive 89/6866/EEC
- Authorized Representative
- Post-Market Surveillance
- Risks of Non-Compliance
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