We are among the few Italian Notified Bodies to certify
disposable FFP2 and FFP3 respirators in accordance with standard EN 149.

How to proceed

Before submitting a certification application:

  • Make sure you have performed all the necessary tests in accordance with the applicable standards in force
  • Prepare the necessary technical documentation: technical file and instructions for use

 

At the end of the certification process, affix the CE marking to the PPE and prepare the EU Declaration of conformity (Annex IX to Regulation (EU) 2016/425).

In addition to the EU type-examination (Module B) procedure, ask us for one of the following procedures:

  • conformity to type based on internal production control plus supervised product checks at random intervals (Module C2) as specified in Annex VII to Regulation (EU) 2016/425
  • conformity to type based on guaranteed quality of the production process (Module D) as specified in Annex VIII to Regulation (EU) 2016/425

 

Keep the EU declaration of conformity and the technical documentation for 10 years from when the PPE is placed on the market.

Does the certificate have an expiry date?

The EU Type-examination Certificate Module B has a maximum validity of 5 years from the date of issue, except if the applicable harmonised standard is revised.

Module C2 and Module D are subject to annual supervision.

Consult our Regulations or contact us for more information about the validity of our EU Certificates and the ways we obtain financial economic support.

For complains, claims or notifications, fill in form M33 and send it to qualita@cimac.it.

Do you want to find out more or request a quote?