Dear customers,
In order to comply with all regulatory requirements and MDR medical device regulation (EU) 2017/745, h/p/cosmos performs regular PMS Post Market Surveillance, updated Clinical Evaluation Reports CER and ongoing Risk Management.
In the latest CER file update 2 additional contra-indications have been found in the evaluation of clinical data and literature and a few recommendations have been made, which are incorporated in this addendum of the original instructions for use.