Clinical Evaluation
Is a US-based test dataset mandatory for FDA clearance of dental AI software?
At our company, we are developing dental AI software and are preparing for FDA clearance in the US. We understand that having data from US sources is beneficial, but is it...
Does software that analyzes EHR blood test results meet FDA CDS criterion 1?
Our company has a device that analyzes blood test results, biological sex, and age, with all input information coming from the electronic health record (EHR). According to the...
Does software that provides glasses prescriptions perform a diagnosis under EU MDR?
Our company has developed a device for eye exams that calculates refractive measurements (myopia, hyperopia, astigmatism) and provides values (+ or -) for glasses or contacts....
Can clinical evaluation for a Class I SaMD app rely on literature from similar, but not equivalent, devices?
I am working on the clinical evaluation for a mobile application (Class I, SaMD) that helps people quit smoking. The app features interactive therapy articles with quizzes, a...
Can translated instructional video text be adjusted for lip sync without affecting evidence transferability?
We are preparing to launch our medical device app in a new country and are working with a certified translation agency to translate instructional videos. Our aim is for evidence...
Does providing refractive values for glasses count as a diagnosis under MDR?
Our device is an eye exam tool that calculates refractive measurements, such as + or - values for glasses or contacts, which are then used by an optometrist to issue a...
Is it sufficient to use literature data only for MDR clinical evaluation of SaMD, or is own clinical data required?
We are a software medical device manufacturer currently under risk class I MDD, but will be in risk class IIa under MDR. For the upcoming MDR certification, is it necessary to...
Do DiGA changes need to be reported to BfArM prior to implementation?
Are manufacturers of DiGAs (Digital Health Applications) required to report changes to BfArM before implementing them? How do these requirements compare to those in MDCG 2020-3?...
How to demonstrate clinical equivalence for MDSW when competitor data is unavailable?
We are developing a medical device software (MDSW) that appears equivalent to others already on the market. However, we do not have access to detailed technical descriptions or...
Can an investigator-initiated study qualify as a PMCF study under MDR?
During our ongoing MDR certification process, we have been asked to provide information on a planned Post-Market Clinical Follow-up (PMCF) study. One of our customers, a clinic,...
Can the CER evaluator under EU MDR be an internal employee, and how to manage conflicts of interest?
Is it acceptable for the Clinical Evaluation Report (CER) evaluator under the EU MDR to be an internal person employed by the manufacturer? If so, what steps should be taken to...
How can benefits and risks be quantitatively assessed for imaging software under MDR?
We are developing imaging software and are struggling with how to quantitatively determine the benefit-risk analysis required under MDR. Specifically, it is difficult to assign...
Can anyone recommend a consultant with experience writing a CIP for a Class IIb device?
Could anyone refer any freelance consultants in this community that have experience writing a Clinical Investigation Plan (CIP) for a Class IIb medical device? I might have an...
Is reduced time to triage via telemedicine a clinical benefit under MDR?
For telemedicine platforms that act as medical devices by generating data for review by a medical doctor (such as audio recordings of coughing or skin pictures), the goal is...
What Is Clinical Evidence (MDR)?
We are collecting data to write the clinical evaluation report for our software (class IIa). Our software uses an ML algorithm to detect anatomical structures in CT scans with...
What Is a Clinical Development Plan?
We are writing the Clinical Evaluation Plan and need to include a Clinical Development Plan. What is that and is the difference to the Clinical Evaluation Plan?