Manufacturers of medical devices have to draw up a technical documentation which shall proof conformity with the respective legal requirements.  MDR/IVDR defines in Annexes II and III the required elements:

1. Device description and specification, including variants and accessories
2. Labels and instructions for use
3. Design and manufacturing information
4. Data to demonstrate conformance with the general safety and performance requirements (acc. to Annex I)
5. Benefit-risk analysis and risk management
6. Product verification and validation
   • Pre-clinical and clinical data:
   • • test results e.g. for
     • • biocompatibility
       • electrical safety
       • stability
       • software validation
     • clinical evaluation
   • Additional information required e.g. concerning:
   • • components: medicinal, human/animal tissues or cells, or other substances
     • sterility / microbiological condition
     • measuring function - proof of accuracy

and on post-market surveillance (Annex III):

1. Post-market surveillance plan
2. Periodic safety update report (PSUR) and post-market surveillance report
   

Gladly I will support you in setting up the technical documentation of your products or adapting it to the new requirements.