The new MDR speaks a lot of NBs impartiality and independence, inter alia of Manufacturers they assess. Is that even possible where manufacturers hire the services of NBs, which are essentially commercial entities that need to stay financially afloat? Apparently there's a built-in conflict of interest - the NB would be interested to retain the Manufacturer as a returning client, and a Manufacturer refused certification or heavily burdened in the process would doubtfully be such a client (or any client, for that matter). Strict / fully impartial NBs might quickly find themselves out of business.
Just wondering what others are thinking about it, as it keeps haunting me as I read and re-read the MDR.
Thanks for your opinions,
Ronen.
Just wondering what others are thinking about it, as it keeps haunting me as I read and re-read the MDR.
Thanks for your opinions,
Ronen.