Article 8(1)b of the ATEX directive requires that manufacturers of category 2 mechanical equipment shall lodge a copy of their technical documentation file with a Notified Body of their choice prior to placing the equipment on the market. The file thus records the status of the manufacturer's ATEX compliance.
Key points relating to ATEX Technical File Retention:
- Details of the Notified Body must be included within the manufacturer's Declaration of Conformity.
- The manufacturer must make arrangements for their file to be retained by a Notified Body for ten years after production of equipment within the file ceases.
- When the Notified Body receives a file, they will issue a receipt for the manufacturer’s records.
- Once a file is lodged with the Notified Body it may not be returned to the manufacturer. However, additions can be made to the file.
- The contents of the file are not reviewed by the Notified Body under the rules of Article 8(1)b.
Whilst Article 8(1)b does not provide for the Notified Body to comment on the contents of an ATEX Technical File, TRaC provides this function as an additional service (available on request).