MDD 2007/ - Essential Requirement Checklist - Physical and Biological Properties

D

DuttonT

#1
Hello,

Could someone assist me with the following requirement from the Essential Requirement Checklist?

Chemical, physical and biological properties

7.1where appropriate, the results of biophysical or modeling research whose validity has been demonstrated beforehand.

Thanks in advance
 
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S

SteveK

#2
In our device cases, I have indicated this is not appropriate in the ERs. However, in a past life I did do some modelling of air flow through a particular drug delivery device. This involved computer modelling – specifically ‘computational fluid dynamics (CFD)’. There are now off the shelf modelling packages which will be ‘validated’ for these purposes. Similarly, there are other such packages which could model biophysical interactions e.g. stresses in components such as prosthetic joints (class III devices) etc.:2cents:

Steve
 

bio_subbu

Super Moderator
#5
Hello,

Could someone assist me with the following requirement from the Essential Requirement Checklist?

Chemical, physical and biological properties

7.1where appropriate, the results of biophysical or modeling research whose validity has been demonstrated beforehand.

Thanks in advance
I don’t know the exact information as regards the background and the objective pursued by this provision in the third indent of section 7.1 of Annex I of 2007/47/EC "where appropriate, the results of biophysical or modeling research whose validity has been demonstrated beforehand." However, it appears that the provision aims at requiring manufacturers, when determining the safety of the device in terms of chemical, physical or biological properties, to take account of the results of any suitably validated biophysical or modeling research they or any third party had carried out with respect to the materials used for a given medical device.

In this case, the results of the biophysical or modeling research would need to be part of the technical documentation to be established by the manufacturer.
 
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