Clinical Evaluation Reports per the new MDD 93/42/EEC amendment

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pkost

Trusted Information Resource
#32
That is what we use and it has been reviewed and accepted by our notified body...we claim compliance with the MEDDEV.

The meddev additionally requires that the results of the evaluation feed back into the risk assessment - I don't include that in the actual evaluation but separately as part of our risk management process - you mustn't forget to do that as well!
 
R

Robbie1

#33
That sounds encouraging
I have plenty of clinical study data ie case studies etc
Do you think putting this into a folder with the segments you suggested would be ok
Or do you have to actually write a new report based on the available data
 

pkost

Trusted Information Resource
#34
Although the studies would go a long way, you do have to critically evaluate the data and review it as a whole.

I'm guessing that these are your own case studies, you should also include other data from other sources, similar products, materials etc. You have to justify why you have excluded data sources. The watch words are fair and balanced, this is unlikely to be achieved from your own internal/marketing reports.
 
D

drewsky1

#35
We have been doing Clinical Evidence Reports for our medical devices and are about to update since they have not been done in 2+ years. We are going to discontinue some of these devices in the EU and Australia and the CE mark will be removed. Does anyone know if there are any other market requirements to do CER's besides required by the MDD? I don't believe this is required by FDA or any other international markets. We will continue to do regular PMS's. Thanks.
 

lilybef

Involved In Discussions
#36
For our class 1 sterile device, we have had to provide a Clinical Evaluation for Singapore, UAE, Mexico, Brazil, and Argentina so far apart from the Technical File for the EU. We have not had any requests from other countries, but we are still registering the product in the major markets. FDA does not require one at the moment.

Hope this helps!:cfingers:
 
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drewsky1

#37
Thanks. Do they require an update of the CER at different time periods? Or were these just for the initial registration/dossier?
 

lilybef

Involved In Discussions
#38
It was just for the initial submission. We have not had the product long enough to do any reregistrations, so I am not sure if a new report would be required. If I find out anything, I will let you know!:bigwave:
 
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drewsky1

#39
Thanks, I would appreciate that. I am also going to investigate our international colleagues and will let you know if they can offer any insight as well
 
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drewsky1

#40
In an NB audit for one of our Technical Files, the reviewer noted:

Please submit clinical evaluation that complies with Annex X. It is recommended referring to MEDDEV 2.7.1 Rev 3 (2009)

The Clinical Evidence Report did not note Annex X as a guidline for the report, just MEDDEV 2.7.1 Rev 3 (2009). The later was considered to be the current guideline. Can anyone shed any light on why the reviewer may have noted this for Annex X?
 
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