MDR - annex III - article 1.2
The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.
Periodic Safety Update Report (PSUR)
The technical documentation must contain the periodic safety update report (PSUR). With that, the technical documentation becomes a living document being updated regularly to keep the PSUR section current.
Any questions left? Contact Avanti Europe to discuss with an expert