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Importance of Clinical Documentation in Clinical Trials. The FDA 510 (K) Approval Process. 510k submission. Pre-submissions are made to the FDA for taking feedback about the quality of the file and its content.
They are used for various intensions including meeting requests, to study risk determination, for submission issues, and for FDA feedback to specific questions related to a pending submission or protocol. Premarket approval (PMA) is the FDA process of scientific and regulatory analysis to assess the safety and efficacy of Class III medical devices. EC REP: European Authorized Representative. IVDR CE Marking. The In Vitro Diagnostic Regulation (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices.
From 25th May 2017, manufacturer and economic operators have a five-year transition period for replacing IVDD 98/79/EC to IVDR 2017/746. Manufacturers who wish to make a move with IVDR 2017/746 shall start to apply to a notified body for a conformity assessment of their IVD medical device until the Date of Application of the IVDR before 26th May 2022 to update their Technical Documentation to meet the requirements, as from 26 May 2022 any publication of a notification in respect of a notified body in accordance with Directive 98/79/EC shall become void. The IVDR will come into force on 26th May 2022. I3CGLOBAL UK Regulatory Consulting Services. CLINICAL EVALUATION CHANGES FOR MANUFACTURERS WITH THE NEW REGULATION?
IVDR Technical file. All manufacturers should compile a IVDR technical file in compliance with EU IVDR 2017/746.
The IVD technical file should information about the design, intended use, risk assessment, Clinical and Performance Evaluation and route to conformity with IVDR requirements. The technical documentation may need to be reviewed by a Notified Body (NB) before a CE marking certificate can be issued, depending on the IVD classification and conformity assessment route. Once completed, the technical file must be made available to European Competent Authorities upon request.
CLINICAL EVALUATION CHANGES FOR MANUFACTURERS WITH THE NEW REGULATION? Among the innovations introduced by the European Regulation MDR 2017/745, some require particular attention.
The MDR, with the explicit aim of raising health and safety levels, intervenes on some key elements, such as conformity assessment procedures, clinical investigations and evaluation, vigilance, and market surveillance, while introducing provisions to ensure transparency and traceability of devices. Manufacturers must ensure and document a quality management system and perform a clinical assessment and assurance of compliance with the requirements set by the MDR for each device, including a Post-Market Clinical Follow-up (PMCF) plan. Clinical evaluation is a systematic and planned process aimed at continuously producing, collecting, analyzing, and evaluating clinical data related to a device to verify its safety and performance, including clinical benefits, when used as intended by the manufacturer. .
Clinical Evaluation Report. The clinical evaluation of medical devices is an important activity carried out by manufactures to demonstrate device safety and performance to notified Body for the claimed intended use.
This is demonstrated by way of clinical literatures, clinical experience data and information gathered from the clinical trial(s). The below content is to provide technical guidance to registration applicants for conducting clinical evaluation and successfully document it. The Clinical Evaluation Report contains the results of the clinical evaluation and the clinical evidence on which it is based, in order to support the assessment of the device’s conformity.
Agent or European Authorized representative for Medical Devices: from Directive to the new Regulation.