MDR - GSPR - Annex I - Chapter II

Rincewind

Involved In Discussions
#1
Hello everyone,

I am struggling at the moment with one General Safety and Performance Requirement while updating the Technical Documentation for a product.

In ANNEX I, CHAPTER II one of the requirements is :

10. Chemical, physical and biological properties
10.1. Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in Chapter I are fulfilled. Particular attention shall be paid to: [...]
(e) where appropriate, the results of biophysical or modelling research the validity of which has been demonstrated beforehand;
[...]

Does that mean I need a document which explains the physical principle behind what my device does?

I generally have a hard time understanding this requirement.

Any input would be appreciated.
 
Elsmar Forum Sponsor

monoj mon

Involved In Discussions
#2
(e) where appropriate, the results of biophysical or modelling research the validity of which has been demonstrated beforehand;
What I understood (and subsequently documented a decision in my GSPR checklist) is that, this requirement is saying if you have done any biophysical simulation (something like Computational Modelling!) of your device by following any previously validated method! If so, then document the results.
 

shimonv

Trusted Information Resource
#3
This section talks about the safety of chemical, physical and biological properties. A typical evidence would be biocompatibility and chemical test reports. In this section the physical properties indicates how the device interacts with the patient and healthcare professional for to benefit of conducting chemical and biological tests.
 
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