Lenstec (Barbados) Inc.

Reporting obligations referred to in MDR 2017/745 Articles 87 to 91 are fulfilled 87 – Serious Incidents and FSCA 88 – Trending 89 – Analysis of Serious Incidents and FSCA 90 – Analysis of vigilance data 91 – Implementing acts Be in constant contact and at the disposal of the Authorised Representative to ensure that the Authorised Representative is kept up to date with the regulatory requirements for medical devices in the Union.

The conformity of the devices being manufactured are appropriately checked in accordance with the quality system before being released to the market The technical documentation and the EU declaration of conformity are drawn up and kept up to date The post-market surveillance obligations are complied with in accordance with MDR 2017/745 Article 10 (10) In the case of investigational devices, the statement referred to in MDR 2017/745 Section 4.1 of Chapter II of Annex XV is issued

Obligations are as follows: 1. Confirmation that registration obligations are met as detailed in Articles 27 and 29 of MDR 2017/745. 2. Confirmation that the Technical Documentation and Declaration of Conformities have been drawn up for devices being transferred under the MDR 2017/745 and any new devices thereafter. 3. Communicate any changes in the regulatory field (related to the European community).