There is no debate that under MEDDEV Rev 2.7/1 Rev. 4 and the MDR there is a higher demand for qualitative clinical evidence on medical device safety and performance before and after they are brought to market (also see my previous post on this topic). So medical device manufacturers with presence in the EU better timely evaluate their clinical evidence and seriously consider whether there is a need to start a clinical study now. When your evidence base is sufficient, you may not need to do so, and clinical studies are forever lasting, bureaucratic money-pits, but when your evidence does need strengthening, the latter is exactly the reason why you should initiate a clinical study at this very moment: Starting a clinical study now may give you just enough time to collect your own clinical data before the implementation of the MDR, and running a study in a postmarket setting is less costly and complex than in a premarket setting. Reasons why I think one cannot afford waiting any longer include but are not limited to:
Patient safety – PMCF
To minimize length and cost of premarket studies, patient follow-up in device studies is often limited to the bare minimum and shorter than the intended life-time of the device (imagine the length of a study with an implantable device that is supposed to function for the rest of your life …). Some device issues, however, may become only visible with wide spread and long term use, and following several scandals with implantable medical devices, the EU regulatory bodies, righteously so, became more strict on implementing the device directives with respect to their postmarket surveillance program, especially PMCF. So monitoring product safety in a postmarket setting as well as complying with the EU medical device directives is the number 1 reason to start your clinical study now. Number 2 is that
Clinical studies take time
Clinical project development from idea conception to the first-patient-In minimally takes 9 months: Yes, it is like a baby, you need half a year to come to agree on the design, develop the necessary documents, and then another 3 months to get the necessary regulatory approvals. Patient enrolment and follow-up, very much depending on the type of patient and device, will minimally last another 9 months (thus far I managed one project finishing enrolment several months ahead of plan). Data-cleaning, analysis, and reporting, depending on the size of the study, preparation, and internal procedures, will take at least another 4 months from last-patient-out to study report or abstract. This gives you a minimum of 22 months excluding long term patient follow-up and any delays, and brings us awfully close to the point in time when the MDR is applicable …. A third reason to start your clinical study sooner rather than later concerns the
Clinical study budget
When well thought through, medical device studies in a postmarket setting are less burdensome from regulatory perspective (less approvals, less paperwork, etc), and give more options for a more risk based approach. This makes this type of study more flexible, and – when well run – quicker and less costly. Bringing me to the last but definitely not the least reason to start your clinical study now, and that is
Clinical data access
Under MEDDEV 2.7/1 Rev. 4 and the MDR, it will be much harder to show that your device meets the essential requirements based on equivalence, and if one wants to pursue that clinical strategy one can only use clinical data that conform with the MDD/ MDR and when as a manufacturer you have access to
“… the data relating to devices with which they are claiming equivalence…”,
in other words, you basically need to create your own data-set or have a strong business relationship with the owner of the equivalent device providing you access to their data.
In conclusion, there are multiple reasons to stay away from running a clinical trial, but even more so to start one now. Especially when you are dealing with higher class and implantable devices, when your clinical evidence is in-complete and/ or not according to the regulatory requirements. In such case you cannot afford to wait any longer and to my opinion should start a clinical study as soon as possible.
Please feel free to reach out to me in person or via Applied Clinical Services in case you want to discuss any of the above or are looking for advice or support with your clinical evaluation process or clinical study.