MDR DRAFT DoC

[gabe2jadyn]

Good Morning:

Had anyone put their DRAFT DoC together for the MDR? If so, what verbiage is required for the person signing the document? Is it Company Representative or Person Responsible? Thank you -

 

[emili]

any position that reasonably defined in your company's procedures

 

[ChrisM]

It's as clear as mud in Annex IV of the MDR.... someone who is confident that the product conforms to the EU MDR Regulation and any other applicable (legislative) requirements.

 

[Philip B]

As the DofC is a legal declaration you need someone with the authority to make that legal declaration. Our Managing Director signs ours.

 

[gabe2jadyn]

Thank you for the information! It helped.

 

[gabe2jadyn]

Good Afternoon: One more question, for the MDR DRAFT DoC, do we need the name and address of the Notified Body or just the name and company ID#? Thank you -

 

[Philip B]

Yes, you should state the name, address and number of your notified body on the DoC.

 

[gabe2jadyn]

Thank you!