Annual Product Review of Medical Devices

[tantan]

A colleauge of mine has suggested we do Annual Product Reviews for our medical device. My understanding is that this is only done for pharmaceuticals. Is there any value in doing this for a medical device or should equivalent components of an APR be covered by aspects of the QMS i.e. Management review, analysis of data etc. Also we are only a specifications developer, and it would seem that an APR would be more a review of our subcontract producers data. I would find more value having some form of Annual design review thats pecifcally addresses our role as a specifications developer.

Any input appreciated!

 

[MIREGMGR]

We don't do anything equivalent to a formalized "annual product review".

We have a number of other systematized reviews, though:

1. We annually review product classes that are sold sterile in regard to their sterilization validation.
2. We have mechanisms in place for initiating an immediate review of sterile-packaged products whenever something that might be interpreted as a packaging change has occurred, and products that are produced using a validated process whenever a change affecting that process might be interpreted to have occurred.
3. We would do an immediate review for any product for which post market surveillance / a customer interaction led us to believe that there might be a problem.

 

[qualitymember - 2011]

Are there any softwares out there that can be used to create APR reports. Of course data will be entered into that software/database

 

[SuperGirl]

We don't have a formal Annual Review, but since I'm pretty much started the Quality System from scratch last September. What we do, or at least what is set up is the following (Note: we aren't a spec. developer, we are the initial importer)

1. We have a proceedure set up to inspect all incoming product. To ensure that it is what it is suppose to be and that it didn't get damaged durring shipping.
2. If there are any issue we contact the manufacturer as outlined in our non-conforming procedure.
3. Each year, we review the product classification and code
4. Each quarter we send a review to all of the manufactures detailing the products we recieved, any issues, and/ or follow up regarding.
5. Annual we will be sending an overall review.

In a way we look at all of our products.

 

[pinalbert]

When your product is CE marked, you have to perform annual review of the Technical File. This includes stuff like:
? Change orders
? Post Market Surveillance & Early Warning Feedback reports
? Clinical evaluation reports
? External Standards updates
? Risk Management Reports

And more...

This could be described as an "APR".

 

[dblnkl]

Agree with pinalbert. Suggest that you consult

http://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf.

 

[pkost]

When your product is CE marked, you have to perform annual review of the Technical File. This includes stuff like:
? Change orders
? Post Market Surveillance & Early Warning Feedback reports
? Clinical evaluation reports
? External Standards updates
? Risk Management Reports

And more...

This could be described as an "APR".

In auditee style: where does it say "annual"

Certainly there is ongoing review but changes and events should be assessed to determine the appropriate activities and responses within appropriate timescales.

A summary review may be beneficial to conduct but again it should be appropriate to the device...A novel class III may be monitored more closely with a monthly/quarterly review. A class I, long standing product, such as gauze bandage may be reviewed every 5+ years!