You have questions. wE have answers. let us help you

f.a.q.

Certification Technical File Module C2 CE Marking
What are the Conformity Assessment procedures?

The conformity assessment of products is generally done in two stages, which relate to the product design phase and its manufacturing phase.

4 types of evaluation procedures (or “modules”) are applicable to PPE according to their category:

– Module A: For PPE risk category I

– Module B: For PPE risk category II and III

– Module C and C2: For PPE risk category III

– Module D: For PPE risk category III

Alienor Certification is approved to carry out module B and module C2.

module B module C2
How can I check a certificate is valid?

Send an email to contact@alienor-certification.fr and we will help you check if the certificate is valid. Characteristics that the document should possess: the logos of Alienor Certification, COFRAC, Notified Body number, and signatures. 

Do products have to be tested to the Designated Standard?

Not necessarily.

A manufacturer must ensure the standards or technical specifications they apply help demonstrate compliance with the Essential Health and Safety Requirements (EHSR).

While a Designated Standard may help map EHSR to performance, design and information requirements – and hence make the evaluation process simpler – a manufacturer may submit a product for type-examination that uses any source of standard, external or internally developed – provided this is in a coherent Technical Specification.

However, this must have been satisfactorily reviewed by the Approved Body as meeting the EHSR of the relevant legal instrument. Obviously, this is also subject to a recognised independent test laboratory being able to test against the requirements of the Technical Specification being put forward.  

How do I certify a product when there is no Designated Standard?

Where there is an absence of a Designated standard, the PPE models can undergo Type Examination against a Technical Specification or Protocol put forward by the manufacturer.

Alienor Certification Ltd cannot offer advice or consultation in developing this Technical Specification/Protocol, but will state it in the Review of Application stage. 

Once developed, this must then be reviewed by Alienor Certification Ltd to ensure that the EHSRs of the relevant legal instrument are met. If all this is satisfactory and the PPE models can be tested against the Technical Specification, then the process would continue in the normal way.

Is product certification still valid when the product standard originally used is superseded?

For PPE product certification within the EU, changes to the product standard do not affect the certification unless it can be shown that the original standard did not cover the Requirements of the legislation.  

Although changes to the standard do not invalidate the certification, manufacturers should take note of any changes and consider the implications for their product. 

The certification body and manufacturer are encouraged to consider developments in standards and the market such that continued compliance can be supported. This activity is considered to be a change in the state of the art.

You could apply for an additional certificate or wait until it is time for the renewal of certificate. 


How long does it take for a certification?

It is our policy to give as quick a turnaround as possible, consistent with requirements for due care and accuracy. In any case, when we provide a quote, we include an estimate of the deadline.

The time taken from receipt of samples to the issue of test report varies considerably – depending upon many factors, including current workload, pre-conditioning times, problems with the product or communications during the test programme, etc. 

Please  contact us  and we will advise further.

How much does a certification cost?

The cost of a certification varies considerably on the state of the product, the existence or not of test reports and variations of the product.  

For a quote, please supply specific information, such as a product specification, technical documentation, scope of any quality management system (sites, activities, employee numbers, shift patterns etc), which we will then evaluate.

Please  contact  us and we will advise further.

To whom should I address an appeal, recommendation or complaint about the Certification service?

Please contact our Quality Manager, by email to:  c.hammami@alienor-certification.fr

 Complaints should be addressed to our Quality Manager. Our website provides this facility.

All complaints are acknowledged, registered, recorded and investigated independently and impartially.

The outcome of the investigation is communicated to the complainant.

An appeals procedure is in place, should the need arise.

Can a PPE be marked both UKCA and CE marking?

Yes, goods can carry both, UKCA and CE marking so long as they are fully compliant with EU legislation.

The marking must remain visible and legible and maintain the required proportions.

**Provisions from the UK government:  https://www.gov.uk/guidance/ce-marking 



What should the technical file contain?

The Technical File for a product shall consist of:  

  • Overall and detailed plans of the product, accompanied, if appropriate, by calculation notes and the results of prototype tests, as is necessary for the verification of compliance with the EU Regulation 2016/425.  
  • A list of the safety requirements for the product and of the standards or other technical specifications used to demonstrate compliance with the EU Regulation 2016/425.
  • A copy of the User Information or Instructions for Use supplied with the product.
  • A description of the control and test facilities to be used in the manufacturer’s plant to check compliance of production with the standards or other technical specifications (for Risk Category III products).

 Each conformity scheme will have different requirements. For more guidance, please ask us for information.

Where should the name and number of the Notifed Body appear?

The name, address and identification number of the notified body responsible for the EU type examination shall be included in the User Information supplied with the product.

For products requiring ongoing production surveillance (such as lifejackets, harnesses and earmuffs), it requires the Notified body number of the body performing the surveillance to be displayed together with the CE marking on the product itself. The Declaration of Conformity (DoC), must also state the Notified body number.

Does the test report I have received from my supplier mean that the PPE is compliant?

A test report is a supporting document used by a Notified body to issue a EU Type Examination certificate. You should not rely solely on a test report, as that is not proof of certification.

Which test reports can Alienor Certification accept in support of Module B EU Type examination?

Reports shall reflect the state-of-the-art and be as current as possible. Normally, to be accepted tests reports should be under 5 years. If the test reports are older than 5 years, Alienor Certification reserves the right to request additional supporting documentation, such as recent check test data.

All test reports shall be carried out by an ISO/IEC 17025 accredited laboratory. In the absence of such accreditation, a report will be accepted only when competence has been demonstrated to the satisfaction of Alienor Certification, normally via an internal audit visit.

Is a visit part of the Module C2?

A site visit for assessment of the internal production control is part of the Module C2 control.


Typically, a visit will have to be undertaken by the Notified Body to select samples for product checks. This can occur at the production site, or any other site designated by the manufacturer, provided there are sufficient products to allow appropriate sampling.


In some circumstances, the Approved Body can consider a remote means of sampling – such as review of production records / stock and virtual-video sampling.

What is a UKCA marking?
Why is it needed?

The CE mark must be affixed to many products before they can placed in the European market. It indicates that a product has been assessed by the manufacturer and found to comply with EU requirements for safety, health and environmental protection.

The Personal Protective Equipment (PPE) Regulation is EU Regulation (EU) 2016/425. You can view it by clicking on the link below.

Regulation (EU) 2016/425

How to obtain it?

If you are a manufacturer, distributor or a authorised representative of a manufacturer, you must follow these steps to affix a CE mark to your product:

1- Identify the applicable regulation(s) and designated standard(s)

2- Check the specific requirements of the product

3- Determine if an independent conformity assessment (by an Notified Body) is necessary

4- Test the product and check its conformity

5- Establish and keep available the required technical documentation

6- Affix the CE marking and draw up the Declaration of conformity

Do you need a Notified Body?

For products that pose higher security risks, security cannot be controlled by the manufacturer alone. In these cases, an independent body, in particular, a Notified Body appointed by the European authorities, must carry out the safety check. The manufacturer can only affix the CE marking to the product once this check has been carried out.

Manufacturers of products within Risk Category II and III must go through a Notified Body to be able to affix the CE marking to their products.

Alienor Certification is Notified Body No. 2754 which can provide you with CE certification services for your PPE.

get an estimate