Hi Vinoda,I also asked that question many times, but there was no satisfying answer so far. So here is my personal interpretation:Notified Bodies receive a huge load of requests for conformity assessments. A lot of the applied technical documentations are insufficient (see also https://www.team-nb.org/wp-content/uploads/2022/10/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V1-20221005.pdf, page 3, General Considerations).Notified Bodies are commercial companies, they need to be efficient in order to earn money. With every insufficient technical documentation, they have additional efforts in communication and re-evaluations. Of course, they are happier with valid technical documentation of high quality. So, guess why they ask for involved consultants! They might use this information for the preselection and prioritization of applications...Best regardsChristian
Having worked for a NB, hopefully I can support on the motives of the question.
I agree with Richard's comments around the NB needing to understand your outsourcing etc. However, the main reason for asking this question is around the rules on conflict of interest (similarly for ISO 13845 certification services). A NB already under the Directives needed to show (i.e. it needed to be auditable to NCAs) that they (the specific reviewers, auditors, decision makers etc) involved do not have a conflict of interest with the company or devices under the services being conducted. The rules on conflict of interest and impartiality have become more 'stringent' i.e. more fully defined under the MDR/IVDR - see Annex VII section 1.2. These requirements of impartiality have to be demonstrated and be auditable at all stages of conformity assessment; hence the question/s at application stage that can raise any flags in planning & assignment of personnel. Some NBs are now moving away from using external resources completely as part of their activities, because of complications of CoI and meeting the MDR/IVDR requirements for impartiality. ["The notified body shall be a third-party body that is independent of the manufacturer of the device in relation to which it performs conformity assessment activities. The notified body shall also be independent of any other economic operator having an interest in the device as well as of any competitors of the manufacturer.]
I would further comment that the use of consultants as you say, should help with quality of submissions; and a NB would definitely not be against use of consultants, if it helps increase quality and the review efficiency. Also to comment that NBs do not use the use/or not of consultants to prioritize applications.I trust this helps.
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