ANNEX III
TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.
1. | ▼C21.1. The post-market surveillance plan drawn up in accordance with Article 84. ▼B The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83.
2. | The PSURmanufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 86 and the post-market surveillance report referred to in Article 85.83.
(a) | The post-market surveillance plan shall address the collection and utilization of available information, in particular:
(b) | The post-market surveillance plan shall cover at least:
1.2. The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.