Re: Iso 15223 Or En 980?? What standard should be used in CE technical file?
The latest is EN 980:2008 itself!
I got a doubt, after reading this posting... <snip>
Under the MDD, there is no absolute requirement to meet
any standard, harmonised or not. However some standards are less voluntary than others, and this applies especially to harmonized standards, which are considered to be 'state of the art'.
Thus you will be expected to meet any applicable harmonized standards, or provide a very strong justification as to why not. If you don't, you can expect to receive a non-conformity when the auditor uses the harmonized standard as an audit tool.
Note that the non-conformity wouldn't be against the standard, rather, it would be against Annex I (failing to meet the state of the art).
For non-harmonized standards, the same principles apply, although it can sometimes be a little harder for the auditor to make the case.