Access to ATEX technical file by authorities in special circumstances

Specific circumstances under which the need arises to review the technical file of products having an ATEX acknowledge receipt

Question: for technical dossiers relevant to ATEX directive which are relevant to article 13, paragraph 1, point b), subpoint ii) of the directive 2014/34/EU, which are submitted to a notified body in sealed and unreachable format and subsequently the notified body issues an ATEX acknowledge receipt for them and are maintained by the notified body for a minimum 10 years period, if any inspection of the maintained technical documentation will be requested by EU authorities, because the file is inaccessible, after communicating it to the authorities by the notified body, how the authorities can access to the content of the technical file for the purpose of check?

Answer

1- in brief: authorities can access the ATEX technical documentation because, upon their request, the notified body transmits the sealed or locked file, and the manufacturer is obliged to provide the necessary means (e.g., decryption keys or unsealing authorisation) so that the authorities can examine the content. The notified body itself never inspects the sealed documentation — only stores and forwards it.

2- in detail:

Role of the Notified Body

• The Notified Body does not normally open the file.

• Its duty is to hold the sealed technical documentation and provide it to national authorities or the European Commission upon justified request.

• When requested by authorities, the NB hands over the sealed file in exactly the same format it was submitted.

Role of Market Surveillance Authorities

• The competent EU authorities (e.g., national market surveillance authorities or the Commission) are the only bodies entitled to open and review the technical file.

• Because the file was submitted in a sealed and inaccessible format, the NB cannot inspect it itself but must transfer it as-is.

• The authorities then open and access the content for conformity assessment checks.

 Access Mechanism in Practice

• Typically, the sealed format is physical (sealed envelope) or digital (encrypted archive with no NB access key).

• If inspection is requested:

  • The NB transmits the sealed file to the authority.

  • The manufacturer must provide the decryption key or instructions to the authority, ensuring the authority can access the documentation.

  • Authorities thus rely on the manufacturer’s obligation to ensure that the technical documentation is ultimately accessible to them, even if sealed at the NB.

Legal Basis

• article 13, paragraph 1, point b), subpoint ii) of the directive 2014/34/EU describe these conformity assessment procedures.

• Article 6 of the directive 2014/34/EU, sets the obligations of manufacturers to ensure that the technical documentation is available to authorities.

• The “sealed & inaccessible” option only changes who can open the technical file (authorities, not the NB), but does not exempt the manufacturer from ensuring access when required.