CE marking of personal protective equipment, PPE

Purpose

Personal protective equipment is as defined in the regulation:

1. equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety,
2. interchangeable components for equipment referred to in point (a) which are essential for its protective function,
3. connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use.

It is the manufacturer's responsibility to ensure that the product meets the requirements of the regulation and that it is CE marked. The manufacturer means any natural or legal person who places the product on the market and who manufactures the PPE, or has it designed or manufactured, and markets it under his name or trademark

In some cases, in the case of simple PPE, the manufacturers are able to establish all the supporting documentation for CE marking on their own. In other cases, the manufacturer must turn to a Notified body. The task of the Notified body is to review the PPE and determine whether the equipment complies to the requirements of the regulation. If the Notified body concludes that the PPE meets the requirements, an EU type-examination certificate will be issued, which the manufacturer can use as part of the documentation required for CE marking. For equipment that protects against serious risks and hazards, a follow-up audit is also required, where a Notified Body either assesses the manufacturer's own control system, alternatively takes samples of produced equipment for testing according to valid EU standard. Which of these options are to be applied is chosen by the manufacturer.

Harmonized standards have been developed, and are applicable, for a wide range of PPE. If the equipment is designed completely according to a harmonized standard, the requirements of the regulation will automatically be met. In cases where a harmonized standard is not applicable, the manufacturer must show how the requirements of the regulation have been met for the intended use of the equipment. RISE performs an evaluation to verify that the requirements are relevant and that they are being met.

Method

• ​​EU Type-Examination (module B)

The process starts when RISE receives an application for EU Type-Examination of a Personal Protective Equipment in accordance with Regulation (EU) 2016/425 from the manufacturer. The technical documentation shall be attached to the application. A special application form is available, and this also describes what should be included in the technical documentation.

If the equipment is designed according to a harmonized standard, it will be used as a basis for testing and evaluation. The technical documentation and the results of the tests are evaluated.

In cases where a harmonized standard is not applicable or not complied with, the manufacturer is obligated to describe how the PPE complies with the relevant essential health and safety requirements, as an attachment the application. The description should also describe how the solutions and the levels of protection achieved have been reached. A plan for evaluation is developed by RISE in consultation with the manufacturer, on how to test the equipment.

• Assessment of produced products (module C2)

The manufacturer applies to RISE for sampling and testing. The equipment shall be categorized Category III and shall have a valid EU / EC type-examination certificate issued by RISE or any other Notified Body. The certificates and technical documentation must be attached to the application (not required if RISE has issued the certificates).

RISE will come to an agreement with the manufacturer on the location for the sampling and the extent to which the testing is to be carried out.

• Assessment of quality system (module D)

The manufacturer applies to RISE for an assessment of the quality system regarding the manufacture of one or more personal protective equipment. The equipment shall be categorized Category III and shall have a valid EU / EC type-examination certificate from RISE or any other notified body. The certificates and technical documentation must be attached to the application (not required if RISE has issued the certificates)

RISE, in agreement with the manufacturer, performs an initial assessment of the quality system on site at the manufacturer.

Deliveries

• EU Type-Examination

If RISE makes the assessment that the equipment meets the requirements, an EU type-examination certificate will be issued. The validity period for a certificate is 5 years, and requires, among other things, that no changes will be made to the equipment, that the harmonized standard is still harmonized or, in the case where the harmonized standard has not been applied, that new knowledge or experiences does not dispute the original assessment.

• Assessment of produced products

RISE compiles a report on the result. If the result shows that the tested equipment meets the requirements, the manufacturer is allowed to use RISE id no as Notified body together with the CE marking for the equipment concerned. Continuous sampling and testing shall then take place at a maximum of 1-year intervals.

• Assessment of quality systems

RISE reports the results in a written report. Any deviations shall be corrected by the manufacturer and reported to RISE. Once RISE has approved the measures, a certificate is issued regarding the production control. This gives the manufacturer the right to use RISE id no as Notified body together with the CE marking on the equipment concerned. Follow-up audits of the quality system must then be carried out at a maximum of 1-year intervals.

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