We have the World-Class Medical Device Clinical Evaluation Consultants for Meddev and have cross-platform expertise and in-depth knowledge in MDR Article 61 & Meddev 2.7/1 Rev.4, to start a project right away!
Trying to do it in-house could involve employee hiring, training, and providing the support they need, all of which will cost your time, money, and finally no assurance of success. Meddev 2.7/1 Rev.4 guides the manufacturers on how to undertake a robust and systematic clinical evaluation and how to demonstrate the scientific validity of the data and conclusions.
Clinical Evaluation Report (CER) review is a part of the Technical Documentation (Technical File / Design Dossier). Generally, 2 months if the NB identifies appropriate Clinical Expert. Contraindications and warnings mentioned in IFU or User Manual must be considered while performing the systematic literature search during Clinical Evaluation. In other way around, IFU or user manual must be modified based on the outcomes of the Clinical Evaluation. Yes, the Notified Body will inform if they require a clinical trial in the below situations and also if the data are insufficient to prove the medical device safety and performance: Clinical risks and residual risks from risk management should be considered for clinical evaluation to prove the safety and similarly, any new risk or adverse effect obtained in clinical evaluation should be reflected in the risk management considering the design or material change, if required. External Clinical Experts are clinical professionals who have expertise in the subject device, chosen and trained by the Notified Body (NB) for the assessment of Clinical Evaluation. They provide advice to the NB with respect to the regulations, guidance, common specifications, and harmonized standards. Readers can download MDR Article 61 (page 55 of 175)Quick Contact
Clinical Evaluation Consultants
MDR Clinical Evaluation in Meddev 2.7.1 Rev.4.
Important changes and corrections in Rev.4 are:
Clinical Evaluation FAQs.
How long does a Notified Body generally take to review the Clinical Evaluation Documents?
How Clinical Evaluation is related to IFU/User Manual?
Will a Notified Body would ever inform a company that the clinical evaluation is inadequate, and need data from clinical trial?
Why the risk management and clinical evaluation process
They are updated regularly to prove the continuing clinical safety and performance of the device or for the need of modification/rejection of device from the market based on the adverse event or new risk observed.External clinical experts - Who are they? What is there role?
Where can I download MDR Article 61?