The PRRC’s duties include: a) verifying device conformity before release, b) maintaining technical documentation and EU conformity declarations, c) adhering to post-market surveillance as per Article 10(10), d) fulfilling reporting duties as per Articles 87 to 91, and e) issuing statements for investigational devices according to Annex XV Section 4.1 Chapter II.
Masqué
ROCHA Carla
The PRRC’s duties include: a) verifying device conformity before release, b) maintaining technical documentation and EU conformity declarations, c) adhering to post-market surveillance as per Article 10(10), d) fulfilling reporting duties as per Articles 87 to 91, and e) issuing statements for investigational devices according to Annex XV Section 4.1 Chapter II.