The Personal Protective Equipment are covered by the PPE 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, belong to the 2nd category.
In order to market 2nd or 3rd category PPE such as face masks in EU, the manufacturers or their representatives in the European Union are required to apply for the issue of an EU type-examination certificate by a Notified Body.
For the last 2 years with the COVID-19 global pandemic, the demand on the face mask increased dramatically and as PPE masks are in the 3rd category of the PPE Regulation, the EU-Type examination by a Notified Body, including production controls and/or Quality management system audit, are required.
MTIC InterCert is a well-known Notified Body for several EU Directives and Regulations with nr. CE0068. We can issue EU type-examination certificates according to Annex V (Module B) to manufacturers of personal protective equipment (PPE) and we can carry out all the conformity assessment procedures set out in Annex VII (Module C2 - conformity to type based on internal production control combined with product tests under official control carried out at random intervals) and Annex VIII (Module D - conformity to type based on quality assurance of the production process) of the PPE Regulation.
With our professional staff, accredited laboratory, and +50 years of experience. MTIC InterCert can support all manufacturers and distributors of half masks through the testing and certification process according to
- EN 149:2001+A1:2009 Respiratory protective devices - Filtering half masks to protect against particles – Requirements, testing, marking
- EN 1827:1999+A1:2009 Respiratory protective devices - Half masks without inhalation valves and with separable filters to protect against gases or gases and particles or particles only - Requirements, testing, marking
For further information and to ask an offer, please visit our website: https://www.mtic-group.org/certification/european-directives-and-regulations/personal-protective-equipment
