What are Regional or National Device Registries for Medical Devices?

SK13485

MedDev QA/RA
#1
Registry as defined by EU is as follows: An organized system that continuously and consistently collects relevant data in conjunction with routine clinical care, evaluates meaningful outcomes, and comprehensively covers the population defined by exposure to particular device(s) at a reasonably generalizable scale (E.g. international, national, regional and health system) with a primary aim to improve the quality of patient care.

My question is there is a reference to the "Registry" in the Reactive part of Post Market Surveillance for Medical Devices, which is also known as "vigilance".

Does anyone know, how this system works? How a medical device is involved or connected to this registry? How can we gather data?

Your response will be very helpful, as I am working on an SOP for Post-Market Surveillance for EU. Thanks in advance :) Have a good day!

SK13485
 

shimonv

Quite Involved in Discussions
#3
Hi SK13485,
"Registry" is a very broad term. With regards to medical devices in the EU there is no such registry to speak off, but there are plans to do something like that; it's called EUDAMED (The European database for Medical Devices).

For the purpose of post-market surveillance, the closest I know off is the MHRA database for alerts and recalls for drugs and medical devices. You can use it for your PMS procedures along with the relevant FDA databases.

Cheers,
Shimon
 

FoGia

Quite Involved in Discussions
#4

dgrainger

Quite Involved in Discussions
#5
Your definition appears to come from the IMDRF document "Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making" and not the EU.
MEDDEV 2.7/1 revision 4 defines it as:
"an organised system that uses observational study methods to collect defined clinical data under normal conditions of use relating to one or more devices to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves predetermined scientific, clinical or policy purpose(s)."​
In some cases you can access these e.g. UK National Joint Registry allows prosthetic implant suppliers to download data extracts showing outcomes of procedures using their products:
Implant suppliers
 

SK13485

MedDev QA/RA
#6
@Fogia,@dgrainger,

Thank you for the correction, clarification and for the links. Yes, I found the definition of Registry from MEDDEV 2.7.1/4 Clinical Evaluation guidance document (June 2016).

I believe, the manufacturers can conduct clinical studies based on age groups, treatments, other stats etc. by accessing these registries from healthcare/research facilities.

Good day!

SK13485:)
 
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