Procter & Gamble Technical Centres Limited

ensuring that 1) the technical documentation and the EU declaration of conformity are drawn up and kept up-to date; 2) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of EU regulation 2017/745 on medical devices is issued.

ensuring that 1) the conformity of the devices is appropriately checked, in accordance with the quality management system; 2) the post-market surveillance obligations are complied with in accordance with Article 10(10) of EU regulation 2017/745 on medical devices for quality purpose; 3) the reporting obligations referred to in Articles 87 to 91 of EU regulation 2017/745 on medical devices are fulfilled for quality purpose.

ensuring that 1) the post-market surveillance obligations are complied with in accordance with Article 10(10) of EU regulation 2017/745 on medical devices for Safety purpose; 2) the reporting obligations referred to in Articles 87 to 91 of EU regulation 2017/745 on medical devices are fulfilled for Safety purpose.