Personal Protective Equipment
PPE are products worn or held by a person for protection against one or more risks to that person’s health or safety.
Regulation (EU) 2016/425 states the requirements for personal protective equipment (PPE). The regulation also covers essential (interchangeable) components for PPE and related connecting, anchoring and/or fastening products.
Three categories
Three categories of PPE are possible: I, II or III. The applicable category is defined by the risk against which protection is provided. The applicable category then determines the conformity assessment procedure(s) to be followed. Proper classification is important. And the summary below might not provide sufficient guidance, so in case of doubt please refer to the PPE guidelines provided by the European Commission (version 3, October 2023) that can be downloaded here.
Or consult a national authority or Notified Body.
PPE Category I
This category of PPE are often products of relatively simple design. They are used during activities such as gardening, dishwashing, or ordinary weather conditions such as cold, rain or sunshine.
Examples of this category are gardening gloves, volleyball knee pads, rainwear, sunglasses, or ski goggles.
Category I includes exclusively the following minimal risks:
- superficial mechanical injury;
- contact with cleaning materials of weak action or prolonged contact with water;
- contact with hot surfaces not exceeding 50 °C;
- damage to the eyes due to exposure to sunlight (other than during observation of the sun);
- atmospheric conditions that are not of an extreme nature.
PPE Category II
PPE in this second category are neither classified as Category I nor Category III. Category II PPE protects against risks other than those listed for Categories I and III. In other words Category II PPE protects against risks that are not minimal but also not lethal or causing irreversible damage.
Examples of Category II PPE are oven gloves, swimming aids, sport shin-guards, high visibility clothes, or bicycle helmets.
PPE Category III
This category of PPE provides protection against the highest risks, such as climbing gear and firefighter clothing.
Examples of Category III PPE are hearing protectors, fall arresters, welding gloves, or life-jackets.
Category III includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to the following:
- substances and mixtures which are hazardous to health;
- atmospheres with oxygen deficiency;
- harmful biological agents;
- ionising radiation;
- high-temperature environments; effects comparable to an air temperature of at least 100 °C;
- low-temperature environments; effects comparable to an air temperature of -50 °C or less;
- falling from a height;
- electric shock and live working;
- drowning;
- cuts by hand-held chainsaws;
- high-pressure jets;
- bullet wounds or knife stabs;
- harmful noise.
Conformity assessment procedures
It is obvious that the applicable conformity assessment procedures are a reflection of the severity of the risks against which the PPE protects. For Category I no involvement of a Notified Body is required, for Category II the product shall be (type) examined by a Notified Body and for Category III Notified Bodies are involved for both the type examination and the conformity of production process. This is laid down in Article 19 of the PPE Regulation.
The table below provides an overview of the conformity assessment procedures or “Modules”, Modules marked with an asterisk* require involvement of a Notified Body. The CE marking followed by the identification number of the Notified Body is only required for Category III PPE, the number shall be of the Notified Body that assessed conformity of production according to Module C2 or Module D.
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Conformity assessment procedures |
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| PPE | Design | Production | Marking |
| Category I | Module A | Module A | CE |
| Category II | Module B* | Module C | CE |
| Category III | Module B* | Module C2* or D* | CE nnnn |
Module A (Category I)
For Category I PPE the applicable assessment procedure is “internal production control” (Module A).
This is the “self-declaration” route in which the manufacturer ensures that product complies with the essential health and safety requirements of the PPE Regulation. The manufacturer also takes all necessary measures during manufacturing to verify to all produced products comply with the essential requirements.
The manufacturer affixes CE marking and draws up the EU Declaration of Conformity.
Modules B and C (Category II)
For Category II PPE the applicable assessment procedures are Modules B and C.
Module B “EU type-examination” is the part where a Notified Body assesses the technical documentation and tests the design of the product. The Notified Body issues an EU Type-Examination Certificate if the assessment is completed positively.
Under Module C (similar to Module A) the manufacturer shall ensure that all products produced under his responsibility are ‘conform to type’, the produced products are identical to the type-examined and documented samples.
The manufacturer affixes CE marking and draws up the EU Declaration of Conformity (DoC).
The Notified Body’s name, number and the EU type-examination certificate reference shall be mentioned on the EU DoC.
Modules B and C2 or D (Category III)
For Category III PPE the applicable assessment procedures includes also Module B “EU-Type Examination” but it is combined with either Module C2 or Module D, at the manufacturer’s choice.
Module C2 is called “conformity to type based on internal production control plus supervised product checks at random intervals”. It is Module C “plus”, where the additional part involves the Notified Body carrying out product checks to verify the ‘homogeneity’ of production and the ‘conformity to type’ of the sample tested under Module B. The product checks are carried at random intervals but at least once a year as long as the product is manufactured.
Instead of Module C2 the manufacturer may choose Module D “conformity to type based on quality assurance of the production process”. In this case the Notified Body assesses, audits the quality assurance or management system of the manufacturing process again to ensure ‘conformity to type’. Unexpected factory visits by the Notified Body may be part of this Module.
The manufacturer affixes CE marking with the identification number of the Notified Body for Module C2 or D.
The manufacturer draws up the EU Declaration of Conformity (DoC).
The Notified Body’s name, number and the EU type-examination certificate reference shall be mentioned on the EU DoC.
The conformity assessment procedure (Module C2 or D) and the involved Notified Body’s name and number shall be also mentioned on the EU DoC.
It is possible to have two Notified Bodies involved, one for Module B and one for either Module C2 or Module D.
More information about conformity assessment modules for other EU directives and regulations can be found in ProductIPedia.
