We are happy about the new amendments on governance, the use of harmonized standards vs Common Technical Specifications, the limited use of delegated acts as well as the amendments on ban of chemicals although for this last item we still need more clarification on a pragmatic approach.With regard to the obligation for economic operators we believe that there is room for improvement and we continue to question the pragmatic feasibility of scrutiny processes for high risk class devices. We note with concerns that the European Parliament report did not react to our recommendations on incident reporting as well as on unbalanced obligations for reprocessors vs manufacturers.
Finally we also call upon EU Institutions to carefully monitor discussions at international level on definitions of medical software and accessories.
Europe should not lose innovative power in healthcare sector and need a mature regulation.
We will continue to share our contribution on this critical matter and will remain attentive to negotiations between EU Institutions which will now intensify.
24 Oct. 2013