The surprising true cost of submitting non-compliant technical documentation to notified bodies
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There has been plenty of discussion regarding what "good enough" means with respect to compliance to the MDR and IVDR. There are many new requirements, and the EU is enforcing much stricter interpretations of requirements that existed under the Directives. A recurring theme is that there will be no “grandfathering” for legacy devices, which means that in some cases significant technical documentation remediation may be required (with similarly significant associated costs). There is also a more explicit emphasis on PMS, PMCF, and continual updates of related documentation. At the same time, the MDR requires much greater transparency of information, as evidenced by requirements such as SSCP, and this will require public disclosure of evidence that manufacturers may previously have considered confidential.
As a result, manufactures may choose to "test the waters" first by submitting technical documentation that pushes the boundaries of what may be perceived to be acceptable. However, does this really save manufacturers money in the long run?
You may be surprised to learn from our former notified body leaders and regulatory experts how much this strategy really costs you. Please join us for this eye-opening discussion!
Amie Smirthwaite, Ph.D. - Head of Clinical Regulatory Affairs, RQM+
Jaishankar (Jai) Kutty, Ph.D. - Vice President of Clinical Services, RQM+
Ron Sills - Senior Principal Specialist, RQM+