PPE produced by Spasciani S.p.A. are subjected to the CE Certification procedure by a Notified Body; this also applies to PED and MED devices.
All devices are also subject to the control of the Production Quality Assurance System according to Modules D of the applicable Directives and Regulations:
PPE: Regulation (EU) 2016/425 (ex Directive 89/686 / EEC)
PED: Directive 2014/68 / UE (ex Directive 97/23 / CE)
MED: Directive 2014/90 / UE (ex Directive 96/98 / CE)
