The new European Medical Device Regulation (MDR, EU 2017/745) replaced the Medical Devices Directive (MDD, 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC) implemented on May 26, 2021; and In Vitro Diagnostic Medical Devices Regulation (IVDR, EU 2017/746) replaced the In Vitro Diagnostic Medical Devices Directives (IVDD, 98/79/EC) progressively from May 26, 2022.
Non-EU/EEA manufacturers of medical devices and in vitro medical devices must comply with the requirements of the European MDD/IVDD/MDR/IVDR. These manufacturers have to CE-mark their devices and gain access to the European /European Economic Area (EEA) market. CE marking signifies that their devices have been assessed and they meet the safety, health, and environmental protection as required.
This webinar will briefly introduce the new European MDR & IVDR and will provide specific insights to help you better understand the regulations and what they mean for you. We will also discuss topics of interest regarding CE-marking.
Topics to be covered include:
• Background and overview
• Key definitions
• Key new requirements/significant changes
• Implementation and timeline
• Additional information