Calculating Basic Risk/ Basic on Risk Analysis - Medical device MDD Class II and up
I am rather new to the regulatory field as well as in my company...having a few basic questions on Risk Analysis / Risk Management.
We are adding new functionality to one of our products, and I´m doing a "quick" (i.e. "...let´s not waste too much time on this...") risk analysis. A very basic risk analysis was done to the product before, and the basic architecture remains the same. The former device was also tested to 60601-1.
Would it be necessary to calculate/evaluate basic risk (risk before any safety measures was made) ? (this was not done earlier either as the risk analysis was mainly done after the product was finished.)
I am uncertain as to the overall regulatory requirement on risk analysis.
Is any manufacturer of medical devices (MDD Class II and up) required to implement 14971? I would be grateful for some input here on the minimum requirements and why (legally speaking) as my company wants to keep efforts at an absolute minimum.