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 Directive (PPED) and PPE Regulation (PPER) describe 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

 

Type-examination

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

In the context of PPE, type-examination is the process by which products are independently assessed against the Basic Health and Safety Requirements (BHSRs) of the PPE Directive, or the Essential Health and Safety Requirements (EHSRs) of the PPE Regulation – these frame 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.
  • 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 bodies 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. 

Product Control

In the context of PPE, product control is the ongoing activity of a manufacturer to control production of PPE described by a type-examination certificate through internal systems, but with an independent assessment of production PPE 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 is repeated annually, with the certificate issued valid for one year. 

Quality System Control Option

In the context of PPE, quality system control is the independent assessment of the 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. This independent step is conducted over a three-year cycle, with the certificate issued valid for three years.  

CE Certification

Whether Category II or III PPE, the certification a notified body such as INSPEC issues is critical to the CE marking and declaration to the Union Market. Member States of the European Union acting through Market Surveillance authorities may make reasoned requests for access to and confirmation of these documents – to ensure the Market operates correctly. 

Additionally, INSPEC recognises that end users, importers and distributors are also more familiar with these documents, and as such with agreement of all of our clients, INSPEC provide the service of responding to all validity confirmation requests/checks. We require that such requests are made through email, with attached copies of certificates sent to This email address is being protected from spambots. You need JavaScript enabled to view it.

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