Recent changes – § 115 – in 2nd edition of ATEX Guideline

Article 31
Information obligation on notified bodies
1. Notified bodies shall inform the notifying authority of the following:
(a) any refusal, restriction, suspension or withdrawal of a certificate;
(b) any circumstances affecting the scope of or conditions for notification;
(c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
(d) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
2. Notified bodies shall provide the other bodies notified under this Directive carrying out similar conformity assessment activities covering the same products with relevant information on issues relating to negative and, on request, positive conformity assessment results.
§ 115 Information obligation on notified bodies
Notified bodies have specific information obligations with regard to their activities, to be provided to the notifying authorities by default or on their request.
The wording of Article 31.1(a) makes reference only to “certificates” issued by notified bodies according to the conformity assessment procedures established in the Directive: EU-type examination certificates (Annex III) and certificates of conformity (Annex V, Annex IX). Taking into consideration that notified bodies can issue also other documents – see section § 109 – called “quality assurance notifications” (QAN), to notify to the manufacturer the decision on approval of quality assurance systems (Annex IV, Annex VII), the legal provision should be intended as addressed to the whole range of activities and documents issued by notified bodies when carrying out the relevant conformity assessment procedures. So, the obligation of information of any refusal, restriction, suspension or withdrawal of a certificate is valid also for the “quality assurance notifications” issued by notified bodies (see also § 5.2.2. “Roles and responsibilities” in “The ‘Blue Guide’ on the implementation of EU product rules”).
Also a notified body which gets knowledge of faulty products, but is neither engaged in the module for EU-type examination nor in a module for surveillance of the manufacturer, should take some action.
If there is no immediate danger, if after contact with the responsible notified body for EU-type examination and with the notified body responsible for surveillance of the production of the faulty product no satisfactory solution after appropriate time is reached, the notified body should inform its own authorities in charge of market surveillance to initiate the adequate measures.
In the case of immediate danger, the notified body should inform its own authority in charge of market surveillance, the notified body for EU-type examination and the notified body for surveillance of the production without delay.

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