Certification of Personal Protective Equipment - PPE | Directive 89/686/EEC

The Personal Protective Equipment, is covered by Regulation (EU) 2016/425, and classified into 3 categories:

  • the 1st category includes PPE with a simple design, intended to protect the person from the risk of minor physical injury.
  • the 3rd category includes PPE with a complex design intended to protect against the risk of death or serious injury of a permanent nature.
  • PPE that does not belong to the above two categories, belongs to the 2nd category.

Before proceeding with the production of a 2nd or 3rd category PPE, the manufacturer or his representative residing in the European Community must request the issue of the EC type-examination certificate from a Notified Body.

The EC type examination certificate is the document whereby the Notified Body certifies that a model of PPE meets the applicable essential health and safety requirements of Annex II of the Regulation. The EC type-examination includes the assessment of the adequacy of the technical design of the PPE through examination of the technical documentation, as well as the examination of a complete sample of PPE, representative of the production envisaged (type of production).

The 3rd category of PPE is also subjected to processes that require the conformity of production type inspection by a Notified Body, according to the requirements of Article 19 of the Regulation.
 

The EC type-examination certificate and surveillance procedures must be carried out by notified bodies, appointed by the relevant Ministry and notified by the European Community and deemed to meet the minimum requirements set out in Regulation (EU) 2016/425.

MTIC INTERCERT SRL is Notified Body with no. 0068 for issuing the EC type-examination certificate to manufacturers of personal protective equipment (PPE) and is authorised to carry out all the conformity assessment procedures specified in the Regulation according to the assessment procedure set out in Annex VII (conformity to type based on internal production control combined with product tests under official control carried out at random intervals) and Annex VIII (conformity to type based on quality assurance of the production process).

 

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