Is the process under which an economic operator such as a manufacturer, importer or distributor ultimately claims compliance with an individual or set of European Union Directive(s) or Regulation(s), and marks their product and declares to the Union Market that their product is safe and legal. 

For products such as personal protective equipment (PPE), this process may require third-party intervention through examination and surveillance. 

The PPE Regulation (EU) 2016/425 (PPER) describes the types of PPE which may be placed on the market under CE marking provisions, and what preparatory steps a manufacturer must submit to, to evidence their declaration. 

The general approach is as described here:

 CE marking requirements

Category I

Category II

Category III

Comply with the Health and Safety Requirements


Compile technical documents



Product / Quality system control

Write EU Declaration of Conformity

Apply CE mark

INSPEC Certification Services offers the third party notified body services described above as type-examination and product / quality system control – for Category II and III PPE. 

Type-Examination (Module B)

In the context of PPE, type-examination is the process by which products are independently assessed against the Essential Health and Safety Requirements (EHSRs) of the PPE Regulation – this frames the end use of the PPE in terms of its ability to offer protection and limit any introduction of hazards presenting a risk to the user, and outline the information which must be communicated to an end user so that such PPE may be used safely. 

PPE may satisfy these Requirements by way of:

  • Meeting a, or set of, harmonized European standard(s).
  • Meeting a technical specification designed to addresses each of the Requirements relevant to the product. 

For Categories II and III, technical documentation must be submitted to a notified body such as INSPEC, which must evidence compliance with the Requirements of the Directive / Regulation. In-short, this documentation is the blue-print of the PPE, describing its construction, constituents, function and bounds of use. 

It is the notified body's task to evaluate this documentation, and examine the PPE through comparison to design principles and testing to verify the applicants claim. Where the PPE does satisfy requirements, a Type-examination certificate will be issued for the PPE. For Category II this will mean the manufacturer can proceed with the mark and their statements. For Category III, the manufacturer must submit to further independent processes. 

Internal Production Control & Supervised Product Checks (Module C2)

This is an option for Category III PPE.

In the context of PPE, internal production control is the ongoing activity of a manufacturer to control production outcomes in conformity with the PPE, as described by type-examination certificate, through applying their documented quality system.  The outputs are assessed independently by testing to the harmonized European Standard(s) or technical specification. 

Production PPE would be sampled by a notified body such as INSPEC, with testing conducted to validate conformity to type and verify homogeneity. This independent step constitutes the product checks and is repeated annually.

Quality Assurance of Production Process (Module D)

This is an option for Category III PPE.

In the context of PPE, quality assurance of the production process is the independent assessment of the documented quality system controlling the production of PPE by means of auditing.

The manufacturer establishes a quality system, for instance based upon ISO 9001, which is then sampled annually by INSPEC under audit to verify that controls effectively allow for the production of PPE to type. For INSPEC, this independent step is conducted over a three-year cycle, with the certificate issued valid for a maximum of three years.  


The PPE Regulation, EU 2016/425

<< Previous:  Standards explained

Next:  UKCA Marking >>