EU MDR Clinical Evaluation
We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.
Clinical Evaluation is an ongoing procedure to collect, appraise and analyze clinical data on a medical device (or its equivalent) to conclude whether there is sufficient clinical evidence for compliance with relevant General Safety and Performance Requirements (GSPR). Clinical Evaluation is required for all medical devices (MDR, Article 61).
Clinical Evaluation is part of manufacturer QMS and should be aligned with and reflected in Risk management, Post-market surveillance (PMS), Post-market clinical follow-up (PMCF) plan and, where appropriate, the PMCF report; and Instructions for use.
Our team can assist you with various clinical evaluation tasks, including:
Build a strategy to waive or reduce additional clinical investigations
Write Clinical Evaluation procedure
Write or review Clinical Evaluation Plan
Write or review Clinical Evaluation Report
Analyze and demonstrate equivalence to the comparator device
Review or update a Summary of Safety and Clinical Performance (SSCP)
Review or update a Periodic Safety Update Report (PSUR)
The Notified Body expectations regarding the Company’s clinical evaluation process and documentation are clearly presented in the guidance of the MDCG 2020-13 Clinical evaluation assessment report template (July 2020).
Clinical Evaluation should be based on the Company Clinical Evaluation Plan (see MDR Article 61 and Part A of Annex XIV). The clinical evaluation results and the clinical evidence on which it is based shall be documented in a Clinical Evaluation Report (CER).
For more information, please contact the BioReg team.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.