EU MDR Technical Documentation - Defined Review

[YellowQCPro]

Hello Elsmar!

Can someone point me in the right direction please?

I am looking for any defined requirements that speak to technical documentation maintenance performed by the design holder. I am used to have an internal process that defines the frequency of the review of the technical documentation to ensure it's up to date.
I reviewed EU MDR 2017/745 but could not see where it is required to perform a technical documentation review, define a frequency, gather objective evidence of the review, etc.

Any guidance is appreciated! Thank you!

 

[Billy Milly]

Hi, I don't believe you will be able to define the frequency or interval. Technical documentation should always be up-to-date while needs for updates arise from changed inputs - all standards used for demonstration of conformity, for example. So, if the standard changes, you should update your documents/records proving compliance, if requirements in the standard(s) changed. If nothing changes, no update.
I believe the only explicit part mentioning "TD updates" in MDR is related to PMS requirements.

 

[Orca1]

The requirements are continuous not periodic. Documentation and QMS must be maintained and updated always, and the manufacturer's internal processes should ensure that technical documentation is always up to date and in compliance.

 

[Tidge]

The requirements are continuous not periodic. Documentation and QMS must be maintained and updated always, and the manufacturer's internal processes should ensure that technical documentation is always up to date and in compliance.

What sorts of medical devices and classifications do you have experience with?