Pepgra summarizes key revisions to MEDEV 2.7/1 (June 2016).
A clinical evaluation guide for manufacturers and notified bodies pertaining to 90/385 and 90/42.
Implications for medical device manufacturers.
The recent MEDEV revision is elaborate; however, the 2.7/1 provides us guidance and clarity on the current requisites instead of outlining of new regulations. Table 1 below shows you how to be compliant to the new updates and clarifications enshrined in the MEDEV regulations. Plethora of lengthy support is written for device manufacturers on how to undertake a thorough and diligent clinical trial (CT) assessment. And more importantly the MEDEV revisions answer key questions pertaining to validity and reliability of scientific data and inferences.
Pepgra regulatory affairs pros help you at every phase of the cumbersome documentation or evaluate your will assess all new applications including new certifications and renewals in light of revision 4.
The table below illustrates the important clarifications and changes and more importantly what you need to do as a device manufacturer.
|Table 1: MEDEV revisions—key points you need to reckon with.|
|What’s new?||What’s the topic?||But which clause?||So what should I do?|
|a)||A new clarification.||CER update periodicity||6.2.3||This section helps you to justify and document the periodicity of updates for high risk (annually) and new medical devices (2 – 3 years). You must classify the risk pertaining to the device if you get information from post-marketing surveillance data and reports.|
|b)||A new requirement||Credentials of assessors and authors—declaration of interest.||6.4||You must document to justify lack of relevant academic credentials thru a declaration of interests. New requirements deem assessors, authors to possess relevant academic and professional experience. If the degree is not relevant then you must show 5 – 10 years of professional tenure. This section guides you on how to go about this.|
|c)||A new clarification.||Clearer objectives—safety, performance, and risk.||7||According to revision 4, you must connect objectives of the CER to specific safety, performance, and risk-benefit endpoints. Refer details in section 7 and Appendix 5 and this section shows you how to go about it.|
|d)||A new clarification||Documenting state-of-the-art.||8.2||This section helps you to establish and document state-of-the-art and other treatment alternatives. You must establish safety and performance of device, establish its equivalent device’s risks and benefits too.|
|e)||A new clarification||Methodological quality and scientific validity.||9.3.1||You must document various factors that influence the completeness, objectivity, and weightage of data; hence, you must reveal the scientific validity of data in addition to statistical considerations of the study. The section highlights factors that affect the scientific validity of different types of datasets and includes the following:
|f)||A new clarification||Clinical, biological, and technological equivalence.||Appendix 1||This section assists you to document design differences and their impacts on clinical safety and performance in addition to comparative drawings and diagrams. Also, show that the device does meet all three categories of equivalence.|
|g)||A new clarification||Ease of data access—equivalent devices.||Appendix A12.2.3||You must show the notified body (NB) your data access of the equivalent devices. In other words, you have a contract in place allowing access to data for competitor devices for which you claim to have equivalence. This section guides you exactly how to go about this.|
|h)||A new clarification||Ascertaining the need for clinical evidence.||Appendix 2||This section guides you on how to check whether your clinical evidence will suffice or not.|
|i)||A new clarification.||Risk-benefit profiling||Appendix 7||This section guides you on how to do a risk-benefit analysis data to demonstrate device safety and performance and talks about the following:
|j)||A new clarification.||Follow up activity to PMS.||Appendix 12||This is called post-marketing clinical follow up (PMCF) and revision 4 stresses the connection between PMCF, PMS, and CE. Hence, you must organize your PMCF and validate it according to the data and inferences written in the CER and this section show you exactly how to carry out this task.|
To know more about medical device regulations, please contact Pepgra CRO experts.
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