The European Union (EU) Medical Devices Regulation (EU 2017/745) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU 2017/746) (IVDR), now apply. Important terms used in the regulations are ‘entry into force’ and ‘date of application’. The publication of the text in the Official Journal of the European Union was on 5 April 2017. The ‘entry into force’ was the date when each regulation came into effect, twenty days after publication. The ‘date of application’ reflects the date from which the requirements apply and the Active Implantable Medical Devices Directive (AIMDD - 90/385/EEC), Medical Devices Directive (MDD - 93/42/EEC) and In Vitro Diagnostic Medical Devices Directive (IVDD - 98/79/EC) were repealed.
Scarica oggi stesso questo white paper per saperne di più sull'implementazione delle normative sui dispositivi medici dell'Unione Europea.
