Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), technical documentation is no longer a one-off submission, it is a living file that Notified Bodies expect to be current, coherent, and traceable at any time.
Keep it living, not static
Clinical evaluation, post-market surveillance, and risk management feed each other. A change in field experience should flow through your PMS reports into the clinical evaluation and, where needed, the risk file. Documentation updated only at recertification is a common source of findings.
Traceability is everything
Every claim should trace to evidence, every requirement to a verification, and every residual risk to a justification. Notified Body reviewers follow these threads, and orphaned claims are where reviews stall.
Expect scrutiny of clinical and performance evidence
Both MDR and IVDR raised the bar on clinical and performance evidence. Map your evidence to the General Safety and Performance Requirements early, and be candid about gaps and how the PMS plan will close them.
Treated as an integrated system rather than a binder, your technical documentation supports faster reviews and a more defensible CE mark.