Post-market clinical followup studies (PMCF)

#1
Hi!
Based on MEDDEV 2.12/2 recommendations:
PMCF studies can follow several methodologies, for example:
a. the extended follow-up of patients enrolled in premarket investigations;
b. new clinical investigation;
c. review of data derived from a device registry; or
d. review of relevant retrospective data from patients previously exposed to the device.
1. Is it obligatory to perform the PMCF of patients? Please, give us a detailed explanation of sec. c and d.
2. Can we study only patients from EU countries or we can use patients from other world regions?
3. Is there any other alternative of PMCF? Can we skip it?
 
Elsmar Forum Sponsor
#2
Hi Aleksandra,

1. Short answer: it depends.
Longer answer: it depends on the risk class and general safety and performance of the device, and how it interacts with patients/users. For example, an implantable device will most likely require that PMCF studies are conducted, although I can't say for certain what types would be required (I don't have any experience with implantables, so maybe someone else can shine some light on that). Devices intended for high-risk populations, high-risk anatomical locations, or for severe disease/treatment challenges generally require them.

A good way to determine if PMCF studies are needed is by using the MEDDEV 2.12/2 Section 5 criteria. There's a really great list that can be formulated into a checklist. I'd suggest bringing this into your QMS as a PMCF Determination Form. Decide yes or no for each line, with a justification - this should put you on the right path to determining if they are needed, as well as providing evidence that your decision was formulated based on the guidance and not just a guess.

2. This depends on local regulations, I would think. Where are you marketing the device? How does the device interact with the patient/user? Some countries require that clinical data include persons of that nationality. Others accept foreign clinical trial data. Again, it depends.

3. Yes, there is, but again, this depends on the device in question. Another example: suppose you are a manufacturer of an x-ray tube. This is a higher class device that requires exposing the patient to radiation to get images for diagnosis. You'd think that something so potentially dangerous would require PMCF, right? Looking closer, we see that the tube itself does not interface with the patient, and that the technology is already well-known and established as being safe. From the MEDDEV guidance, "PMCF studies may not be required when the medium/long-term safety and clinical performance are already known from previous use of the device or where other appropriate post-market surveillance activities would provide sufficient data to address the risks". How long has your device been marketed? Have there been any significant changes to the design that may impact patient safety? Is the technology long-standing and regarded as safe? Depending on your answers to these questions, complaint handling, PSURs, database searches, tracking and trending, etc., may be enough to determine if there are any emergent clinical risks, or a need to update the RBA.

Hope this answers some of your questions! Maybe someone with a little more experience can chime in.
 

SKM.Sunil

Involved In Discussions
#3
Hi!
Based on MEDDEV 2.12/2 recommendations:
PMCF studies can follow several methodologies, for example:
a. the extended follow-up of patients enrolled in premarket investigations;
b. new clinical investigation;
c. review of data derived from a device registry; or
d. review of relevant retrospective data from patients previously exposed to the device.
1. Is it obligatory to perform the PMCF of patients? Please, give us a detailed explanation of sec. c and d.
YES
2. Can we study only patients from EU countries or we can use patients from other world regions?
YES- You can perform from all over the world
3. Is there any other alternative of PMCF? Can we skip it?
NO - PMCF is mandatory as long as your device is intended for human use. (excuse PMCF Studies)

c. review of data derived from a device registry; or
There are major device registries around the globe, major to mention- MAUDE, MHRA registry, TGA registry, etc...
when there is a reported event for a device similar/equivalent to your device, you can always collect the data/analysis report on the relevant event and evaluate it with your device, how it may or may not affect your device while use in forcible or nonforcible intend.
<This method require very explanatory demonstration how to do it ......I would suggest you should run a research on your own.....if you want I can help.>

d. review of relevant retrospective data from patients previously exposed to the device.
As per PMCF your device is already in the market and used on patient. You can adopt a cleaver way to trace the patients/humans used your device till date and collect the device data from them like how it performed and safety complications.
you require to take help from doctor and ethics committee approval to perform certain studies like this kind.
once you set you can target the regions and collect the data and evaluate and frame a report.
<This method require very explanatory demonstration how to do it ......I would suggest you should run a research on your own.....if you want I can help.>
 

Watchcat

Trusted Information Resource
#5
There are major device registries around the globe, major to mention- MAUDE
MAUDE is not a registry, in that no devices or patients are registered there. MAUDE contains data taken from the reports of issues with medical devices that submitted to FDA by device manufacturers, healthcare providers, and patients. FDA has a device registry, which is its registration and listing database. This database does not include any data on the devices that are listed in it. They are just listed.

MAUDE is a legacy database. It is accurately described as containing data "taken from reports," not data about devices identified in the reports. The data are junk and shouldn't be used for much of anything. If you don't believe me, believe FDA. It says so in a bulleted list of caveats posted on the MAUDE search page, where anyone who is interested in the quality of the data in the MAUDE database can't miss them. I expect most of the other databases companies search for the sake of searching have similar problems, although perhaps the owners of some of these other databases are not so transparent about their limitations.

If you want useful postmarket data from a registry, you must design and populate it yourself, which some companies do. Other companies have been scrambling around for the past several years, trying to figure out how to avoid setting up their own registries, or otherwise collect postmarket data on use of their devices. One approach to this avoidance is to use data for their purposes that they find in databases that were set up by other entities (e.g. regulators, health organizations) to serve the purposes of those who set them up.

I don't think this is going to work out well for these companies over the long haul. How long a haul it is likely to be...in the EU, that depends on the NBs that are designated under the MDR, and maybe also whatever replaces the current MEDDEVs, post-MDR. Otherwise, we wait for another "PIP" to inspire further scrutiny of the industry's postmarket surveillance practices.
 

SKM.Sunil

Involved In Discussions
#7
MAUDE is not a registry, in that no devices or patients are registered there. MAUDE contains data taken from the reports of issues with medical devices that submitted to FDA by device manufacturers, healthcare providers, and patients. FDA has a device registry, which is its registration and listing database. This database does not include any data on the devices that are listed in it. They are just listed.

MAUDE is a legacy database. It is accurately described as containing data "taken from reports," not data about devices identified in the reports. The data are junk and shouldn't be used for much of anything. If you don't believe me, believe FDA. It says so in a bulleted list of caveats posted on the MAUDE search page, where anyone who is interested in the quality of the data in the MAUDE database can't miss them. I expect most of the other databases companies search for the sake of searching have similar problems, although perhaps the owners of some of these other databases are not so transparent about their limitations.

If you want useful postmarket data from a registry, you must design and populate it yourself, which some companies do. Other companies have been scrambling around for the past several years, trying to figure out how to avoid setting up their own registries, or otherwise collect postmarket data on use of their devices. One approach to this avoidance is to use data for their purposes that they find in databases that were set up by other entities (e.g. regulators, health organizations) to serve the purposes of those who set them up.

I don't think this is going to work out well for these companies over the long haul. How long a haul it is likely to be...in the EU, that depends on the NBs that are designated under the MDR, and maybe also whatever replaces the current MEDDEVs, post-MDR. Otherwise, we wait for another "PIP" to inspire further scrutiny of the industry's postmarket surveillance practices.

Thanks for Clarifying more...
 

Wolf.K

Involved In Discussions
#8
MAUDE is a legacy database. It is accurately described as containing data "taken from reports," not data about devices identified in the reports. The data are junk and shouldn't be used for much of anything.
Well, I like to use it, as it is the largest database I can freely access and includes most of our competing products. Our NB likes our analysis of the reports found there, as this data directly feeds into our risk management. What other registers could you suggest?
 

Watchcat

Trusted Information Resource
#9
Once the MDR designation thing settles down, I'm going to do my best to educate the NBs on the worthlessness of the data in MAUDE. I might critique some other registries, too, if I ever get the time.

The registry of implant suppliers referenced by dgrainger above looks promising.

I'm not a fan of registries, especially the ones "maintained" by regulatory agencies. I tend to think they are there mostly so they can say they have one, like a lot of companies have Quality departments mostly for show.

I would recommend a registry based on a complete understanding of what the data in it tell you, which is usually determined by who reports, what is reported, when, and why.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#10
We use MAUDE data for our device type FLL for trends with devices like ours. I pull that data out and pivot table the Sh&^ out of it and present it. Are you suggesting this is not valuable? Maybe I misread your comment.
 
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