This will be shared with your Notified Body. This is the key communication piece for them to understand your plan. Also, share it internally with those who have concerns about the product and know what the product support will be. If there are any products you’ll remove from the portfolio or any portfolio extensions—the reason I continue to emphasize planning and coming back to what will happen under the MDR—if any significant changes are made, you must upgrade that product’s technical documentation to meet the MDR’s requirements. You need to understand what to do before the end of the transition period and how this will affect you as the transition period ends and the MDR is fully applicable. This portfolio planning is key to that. Share internally and with your Notified Body—the people you need to involve.
