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Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ?

#1
Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? We received the 510K for that device last year saying that this material is safe as it has long history of use, so no chemical characterization was done. Do we require to do that fir MDD ? or Literature information and history of safe use is sufficient ?
 
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#2
Eksimar,

refer to ISO 10993-1:2018, which talks about _material_ (i.e. both chemical and physical) characterisation throughout the document, especially in section 6.1 "Physical and chemical information for biological risk analysis" - quote:

Gathering physical and chemical information on the medical device or component is a crucial first step in the biological evaluation [...] The extent of physical and/or chemical characterization required depends on what is known about the material formulation, what nonclinical and clinical safety and toxicological data exist, and on the nature and duration of body contact with the medical device. At a minimum, the characterization shall address the constituent chemicals of the medical device and possible residual process aids or additives used in its manufacture. [...]

If the combination of all materials, chemicals and processes has an established history of safe use in the intended application, and the physical properties have not changed, then it is possible that further characterization and additional data sets (e.g. chemical analysis of extracts or biological testing) will not be necessary. In this case the rationale shall be documented.
So if you have enough existing data at hand to demonstrate compliance to this section, no further material characterisation testing is warranted.

HTH,

Gerhard
 
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