In order to comply with the European Union (EU) Medical Device Directives – 90/385/EEC Active Implantable MedicalDirectives (AIMD), 93/42/EEC Medical Device Directive (MDD) and 98/79/EC In Vitro Diagnostics Device Directive(IVDD) (referred to as ‘The directives’ hereafter), manufacturers must conduct post-market surveillance (PMS).