[Expert Solution]: . A company produces a class IIb medical…

. A company produces a class IIb medical device similar in function and design to product that have been on the market for many years. The NB requests a new clinical investigation be performed. What should the reg.proffesional do first? a. Approach the CA to confirm whether clinical investigations are required b. Discuss with the NB the scientific literature already provided-X c. Indicate that the device complies with European Harmonized standards d. Take steps to initiate a clinical investigation meeting the requirements of Annex X and EN ISO 14155