Medical Device changes - Active implants

#1
Hello,
We are developing an active implant (pre-CE). As we are planning to conduct preclinical studies, the implants we have available at this point have been created by a different manufacturing mold than the one we plan to use to make the implants that are dedicated to humans.
We believe that the change in mold will not affect the safety and performance of the implant and therefore we would like to continue with our preclinical plan and implant the current implant configuration (it will most probably take at least 3 months to manufacture the new mold).
If we plan to submit the preclinical data along with a rationale and bench tests on why these implants are equivalent in terms of safety and efficacy, do you anticipate any problems with the EC or Competent Authorities?

:thanx:
 
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#2
Re: Device changes - Active implants

polish1023,


I am assuming when you talk about preclinical studies you mean activities to support your biocompatibility evaluation? If yes, you may consider demonstrating equivalence by comparing your material characterization data (gained per ISO 10993-18) for the implant when manufactured with the current and future mold, plus a comparative cytotoxicity study (per ISO10993-5): if you end up with an equivalent leachables/extractables profile and an equivalent cytotoxicity potential, you may have a valid rationale for not repeating the tests for all other biological risks.

So in case your rationale is valid, you should be fine for your submission:

Hello,
[...] If we plan to submit the preclinical data along with a rationale and bench tests on why these implants are equivalent in terms of safety and efficacy, do you anticipate any problems with the EC or Competent Authorities?
HTH, Gerhard
 
#3
Re: Device changes - Active implants

In your post you state that "We believe that the change in mould will not affect the safety and performance..."

It may be that the level of concern that a regulatory body will have with the change will depend upon the engineering / scientific rationale to back up your statement. This could be the result of tests performed or strong scientific judgement.
 
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