REGULATIONS

LEITAT NOTIFIED ORGANISM
0162

  • Leitat is a Notified Organism with No. 0162, recognised by the European Community and authorised by the Ministry of Industry, Energy and Tourism to conduct the Conformity Assessment (CE Marking) before Personal Protection Equipment (PPE) included in the accreditation scope and in compliance with the REGULATION (EU) 2016/425 of the European Parliament and Council is launched into the community market for:

    • Module B conformity
      assessment (Category II PPE)

    • Module C2 conformity assessment (Category III PPE)

In compliance with point 4.6 of the UNE EN ISO/IEC 17065 standard, the following information is available upon request by sending a mail to calidad@leitat.org:

  • Certification management procedures (AT-PNT0005, for Module B) and (AT-PNT0011, for Module C2)
  • Price list of the year in effect
  • Description of the rights and duties of petitioners and customers (AT-FR0095)
  • Protocol of use of the Notified Body number (AT-PRO0065).
  • Procedure to deal with complaints and appeals (AT-PRO0055).

Regulation 2016/425

All personal protection equipment (PPE) should be commercialised in the European market in accordance with the standards established in Regulation (EU) 2016/425.
Regulation (EU) 2016/425 sets out the fundamental safety requirements that products and procedures should meet before a PPE is commercialised in the internal market.

In this way, Regulation (EU) 2016/425 facilitates the free movement of PPEs in the internal market in full compliance with the minimum requirements regarding the consumers’ safety (the so-called fundamental requirements).

The technical development of fundamental requirements is based on European harmonised standards, which give a presumption of conformity with the laws.
 
Manufacturers are obliged to affix the EC marking on their equipment as a visible sign of the conformity with the fundamental requirements.
 
The regulation (EU) 2016/425 resorts to notified bodies like Leitat  for several tasks. This is the case for the EU type examination (module B) of PPEs belonging to categories II and III and of the production control of PPEs category III (module C2 or D).

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