Carl Zeiss Vision GmbH

The Person Responsible for Regulatory Compliance is responsible for ensuring compliance with the responsibilities set out in Article 15, acc. to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR), Chapter II, Art. 15.

Business Sector Vision Technology Solutions (BS VTS): - The technical documentation is drawn up and kept up to date. - The post-market surveillance obligations are compiled in accordance with Article 10. - The case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.