EU TYPE-EXAMINATION (Module B)

1. What is EU type – examination?

EU type – examination is a crucial part of the conformity assessment procedure for Personal Protective Equipment (PPE). It involves a notified body carefully examining the technical design of PPE. The main goal is to verify and attest that the technical design of the PPE meets the requirements of the relevant Regulation. This examination is carried out by assessing the adequacy of the technical design through two key methods: examining the technical documentation and inspecting a specimen that represents the planned production of the complete PPE (the production type).

2. How to Apply for EU type – examination?

The manufacturer has the freedom to choose a single notified body and submit an application to it. The application should include several important elements:

Contact Information: The name and address of the manufacturer. If the application is submitted by an authorised representative, their name and address should also be provided.
Declaration: A written statement declaring that the same application has not been submitted to any other notified body.
Technical Documentation: As described in Annex III.
Specimens: Specimens of the PPE representing the planned production. In cases where PPE is produced in series and each item is custom – made for an individual user, specimens representing different user ranges should be provided. For single – unit PPE made for an individual user’s special needs, a basic model should be submitted. The notified body may request additional specimens if necessary for the test program.

3. The Process of EU type – examination

Once the application is received, the notified body undertakes the following steps:

Technical Documentation Review: Examine the technical documentation to evaluate the adequacy of the PPE’s technical design. When doing this, point (j) of Annex III does not need to be considered.
User – Specific PPE Considerations:
- For series – produced PPE custom – made for individual users, review the measures’ description to assess their adequacy.
- For single – unit PPE for individual users, review the manufacturing instructions based on the approved basic model to assess their adequacy.
Specimen Verification: Check that the specimens have been manufactured in line with the technical documentation. Identify the elements designed according to relevant harmonised standards and those designed according to other technical specifications.
Examinations and Tests:
- If the manufacturer has applied solutions from relevant harmonised standards, conduct or arrange appropriate examinations and tests to ensure correct application.
- If the relevant harmonised standards’ solutions have not been applied, carry out or arrange tests to ensure that the manufacturer’s adopted solutions, including those from other technical specifications, meet the essential health and safety requirements and have been correctly applied.

4. Evaluation Report

After the examination process, the notified body is required to create an evaluation report. This report records all the activities carried out during the examination and their results. The content of this report can only be fully or partially released with the manufacturer’s consent, except in cases where the notified body has obligations towards the notifying authorities.

5. EU type – examination Certificate

5.1 Issuance and Validity

If the PPE type meets the applicable essential health and safety requirements, the notified body will issue an EU type – examination certificate to the manufacturer. The validity period of a newly issued or renewed certificate is no more than five years.

5.2 Certificate Content

The EU type – examination certificate must contain at least the following information:

The name and identification number of the notified body.
The name and address of the manufacturer and, if applicable, the authorised representative.
Identification of the PPE covered by the certificate (type number).
A statement indicating that the PPE type complies with the applicable essential health and safety requirements.
References to harmonised standards, if fully or partially applied.
References to other technical specifications, if applied.
The performance level or protection class of the PPE, if applicable.
For single – unit PPE for individual users, the range of permissible variations of relevant parameters based on the approved basic model.
The date of issue, expiry, and, if applicable, renewal.
Any conditions attached to the certificate’s issue.
For category III PPE, a statement that the certificate can only be used in combination with one of the conformity assessment procedures mentioned in point (c) of Article 19.

5.3 Annexes

The EU type – examination certificate may have one or more annexes attached.

5.4 Refusal

If the PPE type does not meet the applicable essential health and safety requirements, the notified body will refuse to issue the certificate and must inform the applicant with detailed reasons for the refusal.

6. Review of the EU type – examination Certificate

6.1 Keeping Abreast of Changes

The notified body needs to stay informed about any changes in the generally acknowledged state of the art. If these changes suggest that the approved PPE type may no longer meet the essential health and safety requirements, the notified body must determine whether further investigation is needed and inform the manufacturer accordingly.

6.2 Manufacturer’s Obligations

The manufacturer is obliged to inform the notified body of all modifications to the approved PPE type and any changes to the technical documentation that may affect the PPE’s conformity with the requirements or the certificate’s validity. Such modifications require additional approval in the form of an addition to the original certificate.

6.3 Ensuring Compliance

The manufacturer must ensure that the PPE continues to meet the applicable essential health and safety requirements in line with the state of the art.

6.4 Requesting a Review

The manufacturer should ask the notified body to review the EU type – examination certificate in the following situations:

When there is a modification to the approved type as mentioned in point 7.2.
When there is a change in the state of the art as described in point 7.3.
At the latest, before the certificate’s expiry date. The application for review should be submitted at the earliest 12 months and at the latest 6 months before the certificate’s expiry.

6.5 Review Process

The notified body will examine the PPE type and, if necessary due to the changes, conduct relevant tests. If the notified body is satisfied that the approved type still meets the requirements, it will renew the certificate. The review procedure must be completed before the certificate’s expiry date.

6.6 Simplified Review Procedure

In cases where the conditions in points (a) and (b) of point 7.4 are not met, a simplified review procedure applies. The manufacturer needs to provide certain information to the notified body. If the notified body confirms that there have been no relevant modifications or changes, the simplified review procedure will be carried out, and the full – scale examinations and tests in point 7.5 will be waived. The costs associated with renewal in this case are proportionate to the administrative burden of the simplified procedure. However, if a change in the state of the art is detected, the regular review procedure in point 7.5 will be followed.

6.7 Withdrawal

If, after the review, the notified body concludes that the EU type – examination certificate is no longer valid, it will withdraw the certificate, and the manufacturer must stop placing the relevant PPE on the market.

7. Information Sharing

Each notified body is required to inform its notifying authority about the EU type – examination certificates it has issued, withdrawn, or made additions to. It should also periodically or upon request, provide a list of refused, suspended, or otherwise restricted certificates and their additions to the notifying authority.
Notified bodies should also inform other notified bodies about refused, withdrawn, suspended, or otherwise restricted certificates and their additions. They should provide information about issued certificates upon request.
The Commission, Member States, and other notified bodies can request copies of EU type – examination certificates and their additions. The Commission and Member States can also request copies of the technical documentation and examination results from the notified body with a valid reason.

8. Record – Keeping

The notified body must keep a copy of the EU type – examination certificate, its annexes, additions, and the technical file (including the manufacturer – submitted documentation) for five years after the certificate’s validity expires.
The manufacturer should keep a copy of the EU type – examination certificate, its annexes, additions, and the technical documentation available for national authorities for 10 years after the PPE has been placed on the market.

9. Authorised Representative

The manufacturer’s authorised representative can submit the application for EU type – examination and fulfill the obligations in points 7.2, 7.4, and 9, as long as these are specified in their mandate