Technical Documentation Support for EU MDR & IVDR

Why Technical Documentation Matters

Technical documentation, often referred to as the technical file, is the backbone of regulatory compliance for medical devices and in vitro diagnostic medical devices (IVDs) under both the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). Unlike the former directives (MDD/IVDD), the MDR and IVDR have significantly expanded the requirements for documentation, explicitly linking device design, clinical evidence, risk management, and post-market surveillance into a single, traceable body of evidence. This shift reflects a broader regulatory trend toward lifecycle compliance, where evidence must not only exist at the point of market entry but continue to be evaluated and updated throughout the product’s commercial life.

From a regulatory standpoint, the technical documentation serves two core purposes: first, to demonstrate that the device conforms with the General Safety and Performance Requirements (GSPR) set out in the relevant annexes of the regulations; and second, to provide a comprehensive, auditable narrative that a reviewing authority or Notified Body can assess without ambiguity. Compliance is not static — it must be demonstrable. For example, a Notified Body may review your documentation at conformity assessment, during surveillance audits, or in response to post-market events. Documents that are inconsistent, incomplete, or poorly linked (e.g., risk controls not reflected in performance data) are a common cause of non-conformities and review delays.

Regulatory agencies now expect a high degree of traceability meaning every claim made by a manufacturer must be supported by explicit evidence within the file. This includes traceability between the device’s intended use, clinical evidence, risk analyses, labeling, and post-market surveillance outputs. A clinical evaluation report (CER) that lacks connection to your risk management file, or a PMS plan that does not feed back into performance data, signals regulatory risk and invites queries. In practice, manufacturers who treat technical documentation as a checklist often discover gaps too late, leading to extended review cycles, additional evidence requests, or even formal compliance actions.

Moreover, the MDR and IVDR require specific content and structure, such as a detailed description of design and manufacturing processes, demonstration of conformity with applicable standards, and adequate justification of clinical benefit. For IVDs, performance evaluation is a particularly nuanced requirement, integrating analytical and clinical performance data proportionate to risk class. Navigating these converging demands without a strategic documentation plan is challenging, especially where multiple regulated markets intersect.

Our approach to technical documentation is rooted in regulatory defensibility and operational clarity. Practical RA not only identifies gaps but ensures that documentation is structured in a reviewer-centric way. We establish clear linkages between sections (e.g., from risk management to clinical evidence), implement traceability matrices, and prepare documentation that aligns with expected Notified Body review patterns. By addressing potential disconnects early (such as inconsistent labeling claims, unsupported risk control justifications, or weak clinical evidence), we reduce the risk of extended review cycles and strengthen regulatory confidence.

Technical documentation isn’t merely a regulatory hurdle, it’s the evidence foundation that supports safe, effective, and compliant market access. Done well, it accelerates review, reduces risk, and builds confidence with regulators and Notified Bodies alike. But done poorly, it can stall approvals, drain resources, and expose manufacturers to regulatory findings that compromise commercial timelines. Practical RA stands ready to guide manufacturers through this critical process with structured, compliant, and reviewer-focused documentation support.