Clinical Evaluation - Is this an ISO 13485:2016 requirement?

[ShRam]

Hi,

I need some clarity in Clause 7.3.7- Design and Development Validation.

This clause briefs, "As part of design and development validation, the organization shall perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements".

Is clinical evaluation, a QMS requirement? Does this mean QMS auditors will also look for Clinical Evaluation Report even though there is no product certification?

Kindly clarify this.

Thanks in Advance.

 

[Ronen E]

The key phrase is "in accordance with applicable regulatory requirements." The QMS requirement is to perform a clinical evaluation wherever there is an applicable regulatory requirement to do so, and an auditor should look for an associated report where the applicable regulatory requirements prescribe such a report.

 

[Watchcat]

The QMS requirement is to perform a clinical evaluation wherever there is an applicable regulatory requirement to do so.

Isn't that redundant? If the regulations require one, then the standard doesn't need to require one. If the regulations don't require one then the standard doesn't either. I'm not clear on what is accomplished by the inclusion of this statement in the standard.

 

[John Broomfield]

This clause refers the organization to the regs for the method of validation not whether device’s design must be validated which of course it must.

 

[Ronen E]

Isn't that redundant? If the regulations require one, then the standard doesn't need to require one. If the regulations don't require one then the standard doesn't either. I'm not clear on what is accomplished by the inclusion of this statement in the standard.

When published standards are written in the most efficient way (i.e. not pointing out anything otherwise deductible) they might end up being misunderstood and mis-implemented. Decades of experience have provided plenty of examples, if one is that curious.
Technically, ISO 13485 could have sufficed with a single sentence - "Just do what the applicable (damn) regulations say!" - to cover the entire regulatory angle.