MEDDEV 2.7/1 Overview

MedDev Revision 3.0 gave manufacturers three options: 

• Conduct literature review
• Perform a clinical study
• A combination of literature review + clinical study

MedDev Revision 4.0 provides much tougher rules to focus only on literature review. However, TüV SüD has extended the MedDev 3.0 until May 26, 2020 and manufacturers must have a plan to utilize Rev 4 after the May 26th date.

What we heard from our clients on manual processes

We spoke with over a dozen of clients in regards to how they currently conduct their Clinical Evaluation (prior to using Perta.io), and we wanted to share the results;

• Sources Manual searches across PubMed, Cochorane, NIH, Google Scholar (and other sources) and ClinicalTrials.gov.
• Documentation Download the data from the different sources into an Excel sheet or word document.
• Curation Skim through the titles and abstract to manually mark the relevancy of each publication.
• MedDev Criteria Manually create an respond to each one of the MedDev criteria questionnaires, and manually move a publication to the exclusion and included list
• Publication Review Either search google for free article or PubMed
• Adverse Event Database Sift through the Maude database to manually create a pivot report showing the # of Malfunction, Death, etc .
• Reports Using manual processes, once again to document all the search criteria, identify the flow of the process showing the number of included, excluded and state of the art publications.
• Gather Publication Criteria Using an excel sheet with all the bibliography, they gathered the publication details in regards to the Study Design, Study Objective, Safety Outcomes, and more...
• State of the Art Some used a word document and others used a tabular excel sheet to document the state of the art

Such manual processes are time consuming and have great room for error, causing compliance issues. 

Perta can do better!

What about a tool that can automate your entire CER? Check out Perta.io