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Dear all, does anyone has insights into the interpretation of Article 45 of the MDR (Article 41 in the IVDR). It sais that as part of the market surveillance activities, there is a change that the competent auhorities will review the technical documentation of a product and that this may happen off- or on-site. I think this can be interpreted in two ways – either the CA will review the technical documentation during an audit of the NB or the CA audits the technical documentation during a NB audit of a manufacturer. Do manufacturers need to consider an authority sitting on the table during a NB-surveillance audit? Looking forward to see your thoughts on this. All the Best Makus source: https://www.linkedin.com/groups/2070960/2070960-6379011629631172609 Marked as spam
 Posted by Asked on March 12, 2018 12:00 am
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Private answer
Eckhard Jokisch
From speaking to CA representatives and an NB there is no doubt that this is not an exclusive "OR". So there will be assessments at the CA's desk (off-site) and at the NB's premises (on-site).
In case the CA or a joint assessment has serious doubts on the conformity of a specific NB this may end up in the CA assessing the NB while the NB is assessing a manufacturer - at least if the NB's procedures include the option to assess the documentation at the manufacturers site. In either case the CA will have access to the manufacturers documentation at some point. Does this answer your question? Marked as spam
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Private answer
Dr. Markus Lantermann , This is a good question as the wording in article 45 is ambiguous. Our interpretation is that the goal objective here is that the authority will be reviewing the Notified Body, not the manufacturer. Article 45 is giving the Competent Authority the right to conduct this review at either the location of the Notified Body site, the site of the Competent Authority or other location of their choosing. In the case that a specific Notified Body assessment is under review, the manufacturer shall cooperate with the C.A. as requested. While the C.A. has the right to arrive on site of the manufacturer, this article is not specifically referring to that instance.
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