What are Regional or National Device Registries for Medical Devices?

[SK13485]

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

 

[libanese]

great question

 

[shimonv]

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]

I think you are confusing the notion of registry.

Registries are basically prospective observational clinical studies. They can be initiated by the industry or by the authorities. Data can be collected on a voluntary basis or are part of a mandatory process.

Numerous registries have been setup in the are of orthopedics, here are a few examples:

• Startside
• American Joint Replacement Registry - ​Improving orthopaedic care through data.
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[dgrainger]

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]

@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

 

[Ramya]

Hello All,

I have a question on Medical device registry requirements per new EU MDR.
We are looking for an opportunity to run a registry in the Ireland. Also, we are compliant to MEDDEV 2.7.1/4 for Clinical Evaluation. Under new MDR, do we require to present further clinical data? And what are the additional requirements (if any) for observational clinical studies per MDR?

 

[Watchcat]

Is your company a device manufacturer?

 

[Ramya]

Yes. It is

 

[Marcelo]

Per the MDR, you need to continuously gather data, including clinical data, to continually prove that the benefits from your device outweighs the risk (meaning, performing the ‘benefit-risk determination’). Device registries are one of the sources of data.