Technical Documentation Remediation - European Medical Device Regulations | HCL Whitepaper

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Every medical device manufacturer who places a medical device in European market need to comply with European medical device regulations 2017/745 (MDR).This regulation replaces two directives Medical Devices Directive (MDD) 93/42/EEC and Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC .Every legacy medical devices which are CE marked under MDD/AIMDD shall comply with MDR before 2020.All manufacturers need to update their technical documentation from MDD to MDR. MDR remediation involves checking existing technical files against every MDR requirements. This involves gap analysis against new requirements, identification of new requirements /deliverables and remediation of MDD technical documentation . This whitepaper includes the details of MDR requirements and guidelines to understand European medical device regulations. It explains the unique and generic process flow to create and remediate MDD technical files to MDR. Any manufacturer can easily adopt this remediation execution flow for their MDR transition.