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 in password protected status to a notified body, if any inspection of the maintained technical documentation will be requested by EU authorities, which action should be taken by the notified body?
Answer
ConformEx in such special circumstances will
-
refer to the mail box of its company legal mail and open the email including the technical file password, previosuly received from the manufacturer and open the email,
-
have the password;
-
open the technical file and
-
send it to the authorities.
Access Mechanism in Practice
-
Typically, the sealed format is physical (sealed envelope) or digital (locked file).
-
If inspection is requested:
-
in case that the submitted file is in paper form, the NB first opens the sealed package and forward it physically through an official post to the authority.
-
in case that the submitted file is in digital form, the NB will access to the password (received previosuly from the manufacturere) in company legal mailbox, open the file and send it by its legal mail to the authority.
-
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.
