We are about to outsource 60601 testing for several products and are concerned about the implications of the new amendment (edition 3.2).
MDR requirements are for the state-of-the-art while the latest EU harmonization act from March 2020 refers to edition 3.1.
Our outsourced lab is using using Ed 3.1 for their testing and certification.
When will the new amendment take into effect (in the EU and worldwide)?
Should we considered postponing the certification or are we talking about years before labs adopt the new amendment?
Thanks
MDR requirements are for the state-of-the-art while the latest EU harmonization act from March 2020 refers to edition 3.1.
Our outsourced lab is using using Ed 3.1 for their testing and certification.
When will the new amendment take into effect (in the EU and worldwide)?
Should we considered postponing the certification or are we talking about years before labs adopt the new amendment?
Thanks