How to verify the compliance of the technical documentation with current legal requirements?
Verfication of the technical documentation could be performed through a documentation evaluation or a zero audit performed by an external party, which can draw attention to key aspects related to the manufactured products and adapt the technical documentation to current legal requirements.
Who will assess the technical documentation of the product?
Technical documentation may be assessed by an external notified body for participation in a conformity assessment procedure in accordance with the MDD, IVDD, MDR or IVDR. Competent Authorities could oblidge Manufacturer, or Authorised Representative to provide documentation for market surveillance evaluation. Technical documentation should comply with the requirements laid down in those acts.