I think this is a really interesting discussion....
Although it is true that harmonised standards are not required, past experience with our NB (and I'm sure it won't just be limited to just ours) is that they are very resistant alternate approaches to demonstrating compliance if a harmonised standard exists. I would say MEDDEV's also fall under this category.
I would hope that if we pushed hard enough they would back down but to be honest the effort necessary so far has not made it worthwhile.
Although it is true that harmonised standards are not required, past experience with our NB (and I'm sure it won't just be limited to just ours) is that they are very resistant alternate approaches to demonstrating compliance if a harmonised standard exists. I would say MEDDEV's also fall under this category.
I would hope that if we pushed hard enough they would back down but to be honest the effort necessary so far has not made it worthwhile.
BTW, if your "alternative" solution is compliance with an older version of a harmonized standard, all you have left for addressing is the gap.