Hello all,

Maybe this is a basic question for many of you, but I have a doubt regarding the Standards that should be declared on the Declaration of Conformity according with the MDD 93/42/EEC.

The Situation is, the harmonized standard EN 60601-1:2006/A1:2013 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance will be mandatory since 31/12/2017.

During the recertification Audit, we had some findings relating to this:

The test reports are based on the EN 60601-1:2006/A1:2013, and the collateral standars that are aligned with it were tested (with amendments). For example 60601-1-8:2006/A1:2012, this standard is not harmonized with the amendment and the modifications introduced by A1 imply that the product no longer comply the previous version (harmonized).

The collateral standard with the amendment superseded the harmonized standard. So the question is, can I list the 60601-1-8:2006/A1:2012 on the Declaration of conformity? or only the harmonized standards should be listed?

I hope the explanation is clear, please let me know and I will try to describe again. Thanks a million!!

PD: My thought is that the harmonized standards are voluntary and the manufacturer can choose other standards if he can demonstrate presumption of conformity with the Essential Requirements. So, if the product complies with an improved version of the standard should be good to declare it on the DoC. The thing is that in one of the findings the auditors stated that we declared an ISO standard that is not harmonized – this made me doubt.

source: https://www.linkedin.com/groups/78665/78665-6164868428059406339