GMT SARL

- the Technical Documentation - the post-market surveillance obligations are complied with in accordance with Article 10(9); - the reporting obligations referred to in Articles 82 to 86 are fulfilled; - in the case of devices for performances studies intended to be used in the context of interventional clinical performances studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued.

- the Technical Documentation - the post-market surveillance obligations are complied with in accordance with Article 10(9); - the reporting obligations referred to in Articles 82 to 86 are fulfilled; - in the case of devices for performances studies intended to be used in the context of interventional clinical performances studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued.