MDR Annex II Design & Manufacturing info - 'Adjuvants' definition

[s27bax]

Hi,

Please could someone help me to understand what is meant by the phrasing of the word 'adjuvants' used in MDR - Annex II - Design and Manufacturing Information.

(b) complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the​

continuous monitoring and the final product testing. Data shall be fully included in the technical documentation;​

I have looked up the definition of the word but it doesn't seem to work in this context. I am concerned at the moment that I wont be able to comply if I don't understand what it is asking for.

Any help, advise or input would be greatly appreciated. This forum has been a constant source of excellent information but it is the first time I have posted a question.

Fingers crossed

 

[Pads38]

A definition biased to a pharmacologic agent:

"Agents that aid or increase the action of the principle drug or that affect the absorption, mechanism of action, metabolism, or excretion of the primary drug in such a way as to enhance its effects."

Now think of it as something that boosts a manufacturing process, instead of a pharmacologic process. Hopefully that helps to understand the requirement.

(Hat-tip: mondofacto.com )

 

[s27bax]

Ahh, lightbulb moment Thanks Pads38

I could only find pharmacological definitions and couldn't make the connection to general medical device manufacturing.

Would an example be; for a silicone mould, applying a release agent to help release the moulded part from the mould tool? That would be an agent that facilitates the removal of the device in the manufacturing process. Would this be an example do you think?

I would be grateful to anyone else who can provide examples.

Thanks

 

[planB]

s27bax,

in my view you are on the right track: adjuvants in 3 (b) are any chemicals/manufacturing aids used during processing, such as cleaning agents, mold release agents, lubricants etc.

In my view, the purpose of explicitly spelling out these chemicals is that you should evaluate not only the materials used in the device, but also the processing of the materials, the manufacturing methods, and potential residuals from manufacturing aids used during the process.

HTH, Gerhard