Biologic Evaluation based on ISO 10993-1

#1
Does anyone have any opinion on Biological evaluation based on ISO 10993-1? I work on a Class I Medical Device's company that is still in progress for MDR transition. In the technical file, we only include an overview of the biological evaluation table. The EU AR comment on it does not show the full process and suggests the evaluation should reflect the entire process (ISO 10993-1).
I do not really understand what the "entire process" means.
Is the entire process means a biological evaluation report? May someone guide me on this?
I was wondering if someone could share a template or an example.

Thank you. Regards.
 
Elsmar Forum Sponsor
#2
The entire process means all handling steps that are related to the the product, not only meaning the product use but also related measurements like reprocessing that needs to be taken into account in the biological testing. E.g. cleaning of a medical device can lead to residues on it and thus these residues needs to be (biological) evaluated (and later rated in the CER) - so if for example cleaning is recommended in e.g. your description how to handle the medical device, then this needs to be taken into account...... As this is very individual depending on your product, its use and your handling information etc. its hard to share an example.
 

planB

Super Moderator
#3
CanChua,

the "entire process" is described in ISO 10993-1:2018, especially section 4 and depicted in Figure 1 therein.

On a very high level: Based on your defined intended use, you develop an biological evaluation plan that defines the evaluation and test activities you intend to perform within your risk management process. The related output is then put together in your biological evaluation report.

As I wrote already here: ISO 10993-1:2018 requires its application by experienced and knowledgeable professionals. Without previous exposure to this topic, I would strongly recommend to seek professional support; a shared template would probably not be sufficient.

HTH,
 
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