when things change in the medical device industry world it's best to be on top of it so let's talk about what changes were brought in the 2022 version of the iso 14155 standar

my name is maria niaker and i've spent the last 15 years working with medical devices clinical development and clinical evaluation in fact i teach the course called introduction to clinical investigations of medical devices and the iso 14155 standard you can register for this course by going to medicaldevicehq or by clicking in the link below the video if you're new here subscribe to our channel and click on the button to receive a notification when we post a new video we promise they're really good so let's dive into the standard now we're going to take a look at the major changes in the 2020 edition of the iso 14155 standard compared to its previous version i will also share with you what changes i personally find most helpful and some of the highlights of these updates the new version emphasizes the role of clinical evidence as presented in the european medical device regulation the mdr the new addition also provides clarification on the applicability of gcp to the different clinical development stages this is so valuable when writing clinical development section on the clinical evaluation plan the sep as defined in the mdr the main goal of the changes is to ensure that the standard continues to keep its global acceptance by the regulatory authorities worldwide conducting your clinical studies according to gcp is not only important for the regulatory compliance in the european union the u.s food and drug administration fda also accepts clinical data collected outside the u.s under the condition that the iso 14155 gcp standard has been followed some of the major changes in the 2020 version include the summary of the gcp principles as we described in clause 4. it also includes a reference to the registration of clinical investigations in publicly accessible databases this means that you have to register the data of your study in a database that's accessible to the public such as clinicaltrials.gov or udomed it also provides guidance on risk-based monitoring and considerations when writing the monitoring plan this means that you can determine the extent and nature of monitoring that you consider appropriate for the clinical investigation and based on the risk assessments after you have done taking into account the study objectives the design the complexity the size of your study critical data points and endpoints and the degree and deviation from normal clinical practice management principles also have to apply to the process of clinical investigations this means that you need to ensure that the clinical investigation and estate are compliant with the iso 14155 and the clinical investigation plan the cip and any subsequent amendment the description of and justification for statistical design and analysis must be covered and the objectives should serve the purpose of the clinical investigation and should relate to the hypothesis if any and the endpoints relevant to the target population any claims that you make must be linked to the eligibility criteria for subjects and users the content of nxg is intended to provide the guidance and best practices for the operation of the ethics committee involved in the review of the clinical investigation of the medical device nxh provides an overview of the application of risk management to the standard it includes iso 14971 on clinical investigations so the iso 14971 provides the general framework for systemic management of the risk associated with the use of medical devices and perhaps the biggest update in the 2020 version is this stronger emphasis on risk management principles and the application of iso 14971 across all components of clinical investigations because this is different compared to the 2011 version which only makes reference to the iso 14971 in terms of investigational devices meaning in the pre-market setting the associated risks are estimated risk analysis and evaluated benefit risk analysis and the risks are then reduced to an acceptable level where necessary risk control the effectiveness of risk control is evaluated throughout the product's life cycle including during the clinical investigation a clinical investigation is a method of providing clinical data to allow for conclusions on the acceptability of the benefit risk ratio to all course participants i can only say that i really encourage you to study nxh because i'm sure you will find it very helpful the following nx nxi provides the general indication of possible types of clinical investigations in different clinical development stages this is a very nice schematic overview and it's given table 1 of an xi and finally nxj provides general guidance on the areas that should be examined during the conduct of the clinical investigation audits the sponsor clinical investigation investigation site practices and procedures to determine compliance with this document the standard and where appropriate national regulations i think it's phenomenal that this edition provides clarification on how to apply gcp to different clinical development stages the standards connect contains this really excellent overview in an xi and it provides clarification on how the requirements of the standard are applicable to different clinical development stages i also think it's very helpful to have a section like clause 4 that clearly defines the gcp principles this is very useful in everyday practice because you can go back to it and review it and see really what the purpose of gcp is if you would like to talk about it drop us a comment below we would love to hear from you you could also connect with medical device hq on linkedin and expand your network of people from the medical device industry across the world as always it's been my pleasure and thank you so much for watching bye bye