Just came across this old thread, since I'm deep in the process of reading guidance documents and regulations to prepare updated MDR/recall SOPs for our company. I thought I'd point out for anyone else who happens upon this thread that the new US MDR draft guidance issued July 9, 2013 does formally rescind the 2 year assumption – you now need to request an exemption if you want to avoid reporting additional malfunctions of the same type, regardless of the timeframe in which no injuries have occurred.
Sorry, can't post links to the updated guidance since I don't have enough posts.
Sorry, can't post links to the updated guidance since I don't have enough posts.